CONDUCT RESEARCH AND GENERATE KNOWLEDGE

The impact of the HIV / AIDS epidemic, which has been expanding rapidly and markedly in developing countries, is reaching unprecedented proportions. In order to benefit from research, help fight HIV / AIDS, and to help health systems respond to numerous and complex health problems, it is necessary to focus on knowledge generation and exchange of information from a innovative. In this context, it is essential to ensure that the initiatives of treatment, prevention and control of epidemic benefit from the latest developments, and more relevant experiences.

Research is needed to ensure that decisions are made based on the evidence. The answers that research provides programs and projects that fight HIV / AIDS should be in accordance with local circumstances and realities.
Its main activities are impacting the generation of scientific knowledge and the search for the best strategies to help improve the health conditions of the population. In this line, Impacta done several research projects in collaboration with national and international institutions, and public and private sectors.
"It is essential to ensure that the initiatives of treatment, prevention and control of epidemic benefit both the latest developments, and the latest and most relevant experience ..."

The Directorate of Research relies on the structure and function of the pluripotent IMPACTA PERU Clinical Trials Unit (CTU), whose overarching goal is to contribute to the design and implementation a scientific agenda to control HIV, sexually transmitted infections, tuberculosis and related conditions across the continuum from prevention to treatment, to decrease new infections, reduce associated morbidity and mortality, and ultimately end the epidemics. 

Biography

From 1992 to 2000 I worked as a University of Washington consultant in HIV research and training, with focus on Central America and Caribbean countries.  From 1995 to 2000, I was Director of the Peruvian National STD and AIDS Control Program and Minister of Health´s Advisor.  In 2000, I founded IMPACTA where I am currently the Research Director and started collaborating with different US NIH/NIAID/DAIDS clinical research networks as Principal Investigator (HPTN and HVTN in year 2000; ACTG in year 2003). In 2004, I was awarded the US NIH/NIAID/DAIDS Andean CIPRA and in 2006 was awarded with the IMPACTA PERU CTU, a pluripotent and multidimensional/multilevel CTU serving five US NIH/NIAID/DAIDS clinical research networks (HVTN, HPTN, MTN, ACTG and INSIGTH) through nine CRS. Also, I am investigator on several R01 awards.  I have been deeply involved in the development and implementation of the research agenda of the NIH-funded Networks serving as member of several research committees and member of the HPTN Executive Committee from 2004 to 2005; member of the ACTG Executive Committee from 2005 to 2006, and from 2011 until now; member of HVTN Scientific Steering Committee from 2010 until now, and member of the HVTN Research Ethics and Conflict of Interest (RECOI) committee since 2012.  I will serve as Principal Investigator of the IMPACTA Peru Clinical Trials Unit.

Positions and Honors

Honors and Scholarships

Memberships

Selected peer-reviewed publications 

1. Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlww S, Cowam F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L, HPTN 039 Protocol Team. Effect of aciblovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21; 371 (9639); 2109-19. PMCID: 2650104.

2. Sanchez J, Lama JR, Peinado J, Paredes A, Lucchetti A, Russell K, Kochel T, Sebastian J. High HIV and ulcerative sexually transmitted infection incidence estimates among men who have sex with men in Peru: awaiting for an effective preventive intervention. J Acquir Immune Defic Syndr 2009,51 Suppl 1:S47-51.

3. Maclachlan E, Mayer KH, Barnabas R, Sanchez J, Koblin B, Duerr A. The potential role of biomarkers in HIV preventive vaccine trials. J Acquir Immune Defic Syndr. 2009;15(5):536-45. PMID: 19512938. PMCID: PMC2920071.

4. Fuchs J, Celum C, Wanh J, Hughes J, Sanchez J, Cowan F, Reid S, Delany-Moretlwe S, Corey L, Wald A. Clinical and virologic efficacy of herpes simplex visur type 2 suppresion by acyclovir in a multicontinent clinical trial. J Infect Dis 2010; 201(8):1164-8. PMCID: 2856478.

5. Nicholson O, Dicandilo F, Kublin J, Sun X, Quirk E, Miller M, Gray G, Pape J, Robertson MN, Mehrotra DV, Self S, Turner K, Sanchez J, Pitisuttithum P, Duerr A, Dubey S, Kierstead L, Casimiro D, Hammer SM; for the Merck V520-018/HIV Vaccine Trials Network 050 Study Team. AIDS Res Hum Retroviruses. 2010. PMID: 20854108. PMCID: PMC3422055.

6. Kim HN, Wang J, Hughes J, Coombs R, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Fuchs J, Eshleman SH, Khaki L, McMahon MA, Siliciano RF, Wald A, Celum C. Effect of acyclovir on HIV-1 set point among herpes simplex virus type 2-seropositive persons during early HIV-1 infection. J Infect Dis. Sep 1 2010;202(5):734-738. PMCID: 2964878.

7. Sánchez J, Sal y Rosas V, Hughes J, Baeten J, Fuchs J, Buchbinder S, Koblin B, Casapia M, Ortiz A, Celum C, Male circumcision and risk of HIV acquisition among men who have sex with men. AIDS 2011;25(4):519-23. PMCID: 3120051.

8. Havlir D, Kendall M, Ive P, Kumwenda J, Swindells S, Qasba S, Luetkemeyer A, Hogg E, Rooney J, Wu X, Hosseinipour M, Laloo U, Velosos V, Some F, Kumarasamy N, Padayatchi N, Santos B, Stewart R, Hakim Ch, Mohapi L, Mugyenyi P, Sanchez J, Lama J Pape J, Sanchez A, Asmelash A, Moko E, Sawe F, Andersen J, for the AIDS Clinical Trials Group Study A5221, Timing of Antiretroviral Therapy for HIV-1 Infection and Tuberculosis, The New England Journal of Medicine 2011;365(16):1482-91. PMCID: 3327101.

9. Perla ME, Ghee AE, Sánchez S, McClelland RS, Fitzpatrick AL, Suárez-Ognio L, Lama JR, Sánchez J. Genital Tract Infections, Bacterial Vaginosis, HIV, and Reproductive Health Issues among Lima-Based Clandestine Female Sex Workers. Infect Dis Obstet Gynecol. 2012:739624. Epub 2012 Jun 28. PMCID: PMC3395213. PMCID Journal – In process.

10. Duerr A, Huang Y, Buchbinder S, Coombs RW, Sanchez J, Del Rio C, et al. Extended follow-up confirms early vaccine-enhanced risk of HIV acquisition and demonstrates waning effect over time among participants in a randomized trial of recombinant adenovirus HIV vaccine (Step Study). J Infect Dis. 2012;206(2):258-66. PMID: 22561365. PMC Journal - In process.

11. Beyrer C, Sullivan PS, Sanchez J, Dowdy D, Altman D, Trapence G, Collins C, Katabira E, Kazatchkine M, Sidibe M, Mayer KK. A call to action for comprehensive HIV services for men who have sex with men. Lancet 2012; 380(9839): 424-38. PMID22819663.

12. Sullivan PS, Carballo-Diéguez A, Coates T, Goodreau SM, McGowan I, Sanders EJ, Smith A, Goswami P, Sanchez J. Successes and challenges of HIV prevention in men who have sex with men. Lancet 2012; 380(9839): 388-99. PMID 22819659.

13. Koblin BA, Mayer KH, Noonan E, Wang CY, Marmor M, Sanchez J, Brown SJ, Robertson MN, Buchbinder SP. Sexual Risk Behaviors, Circumcision Status, and Preexisting Immunity to Adenovirus Type 5 Among Men Who Have Sex With Men Participating in a Randomized HIV-1 Vaccine Efficacy Trial: Step Study. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):405-413. PMC 3392543. PMCID Journal - In Process.

14. Campbell TB, Smeaton LM, Kumarasamy N, Flanigan T, Klingman KL, Firnhaber C, Grinsztejn B, Hosseinipour MC, Kumwenda J, Lalloo U, Riviere C, Sanchez J, Melo M, Supparatpinyo K, Tripathy S, Martinez AI, Nair A, Walawander A, Moran L, Chen Y, Snowden W, Rooney J, Uy J, Schooley RT, De Gruttola V, Hakim JG, PEARLS study team of the ACTG. Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings. PLOS Medicine, 1 August 2012, Volume 9, Issue 8, e1001290. PMCID Journal – In Process.

15. Goodreau SM, Carnegie NB, Wittinghoff E, Lama JR, Sanchez J, Grinsztejn B, Koblin BA, Mayer KH, Buchbinder SP. What drives the US and Peruvian HIV epidemics in men who have sex with men (MSM)? PLoS One. 2012;7(11):e50522. PMID: 23209768. PMCID: PMC3510067.

Completed Research Support

5 R01 DE018925.03 (Brander) 08/01/11-07/31/12
Consequence of acute HIV Infection on EBV – Specific Immunity
To evaluate possible effects of acute HIV Infection in the pre-existent anti-EBV immunologic response in HIV high expose subjects and recent retroviral seroconvertors.
Role: Investigator

5 D43 TW008069-02 (Sanchez) 04/01/09– 03/31/11
A Step Forward for Latin American AIDS Research and Training Program (LAARTP)
To establish a curriculum on HIV/AIDS in order to provide specialized training on clinical research in the Latin American region
Role: Principal Investigator

3 R01 AI071212-01A1 (Frenkel) 04/01/06-05/31/11
“Mechanism/predictors of genital/rectal HIV shedding during ART w/plasma <50c/mL”
By characterizing the viral load and genetics in blood, genital tract and rectum over time, this study aims to determine the rate of discordant shedding of virus in the blood plasma and genital tract/rectal; determine the epidemiological factors associated with discordant shedding; and provide further insight into the pathogenesis of expression of virus from activation of latent provirus versus full-cycles of replication with selection of drug-resistant virus
Role: Investigator

1. Llanos-Cuentas A, Echevarria J, Cruz M, La Rosa A, Campos P, Campos M, Franke E, Berman J, Modabber F, Marr J. Efficacy of sodium stibogluconate alone and in combination with allopurinol for treatment of mucocutaneous leishmaniasis. Clin Infect Dis. 1997;25(3):677-84. PMID: 9314461.

2. La Rosa A, Weigand M, Rolston KV. Actinomycosis: an unusual infection presenting as or complicating malignancy. Infectious Diseases in Clinical Practice 2000; 9(8): 331-3.

3. La Rosa AM, Champlin RE, Mirza N, Gajewski J, Giralt S, Rolston KV, Raad I, Jacobson K, Kontoyiannis D, Elting L, Whimbey E. Adenovirus infections in adult recipients of blood and marrow transplants. Clin Infect Dis. 2001; 32 (6): 871-6. PMID: 11247710.

4. La Rosa A, Whimbey E. Section of Clinical Microbiology, Chapter: Respiratory Viruses. In textbook: Infectious Diseases. Second Edition. Lead Editors: Jonathan Cohen, William G. Powderly. Mosby 2002.

5. Zunt J, La Rosa A, Peinado J, Lama J, Suarez L, Pun M, Cabezas C, Sanchez J. Risk factors for HTLV-II infection in Peruvian men who have sex with men. Am J Trop Med Hyg. 2006 May;74(5):922-5. PMID: 16687704. PMCID: PMC2695970.

6. The Strategies for Management of Antiretroviral Therapy (SMART) Study Group, et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006; 355(22):2283-96. PMID: 17135583.

7. La Rosa AM, Zunt JR, Peinado J, Lama JR, Ton TG, Suarez L, Pun M, Cabezas C, Sanchez J; et.al. Retroviral Infection in Peruvian Men Who Have Sex with Men. Clin Infect Dis. 2009; 49(1):112-7. PMID: 19480577. PMCID: PMC2770590.

8. Belloso W, Orellana L, Grinsztejn B, La Rosa A, et.al. Analysis of serious Non-AIDS events among HIV-infected adults in Latin American Sites. HIV Med. 2010;11(9):544-64. PMID: 20345879

9. Neuhaus J, Angus B, Kowalskac J, La Rosa A, et.al. Risk of all-cause mortality associated with nonfatal AIDS and serious non-AIDS events among adults infected with HIV. AIDS. 2010; 24(5):697–706. PMID: 20177360. PMCID: 2897168.

10. Neuhaus J, Jacobs DR, Baker JV, Calmy A, Duprez D, La Rosa A, et.al. Markers of Inflammation, Coagulation, and Renal Function Are Elevated in Adults with HIV Infection. J Infect Dis. 2010; 201(12):1788-95. PMID: 20446848. PMCID: PMC2872049.

11. Firnhaber C, Smeaton L, Saukila N, Flanigan T, Gangakhedkar R, Kumwenda J, La Rosa A, et.al. Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas. Int J Infect Dis. 2010; 14(12):e1088-92. PMID: 20961784. PMCID: PMC3021118.

12. Robertson K, Kumwenda J, Supparatpinyo K, Jiang JH, Evans S, Campbell TB, Price RW, Murphy R, Hall C, Marra CM, Marcus C, Berzins B, Masih R, Santos B, Silvia MT, Kumarasamy N, Walawander A, Nair A, Tripathy S, Kanyama C, Hosseinipour M, Montano S, La Rosa A, et.al. A multinational study of neurological performance in antiretroviral therapy-naïve HIV-1-infected persons in diverse resource-constrained settings. J. Neurovirol. 2011;17:438–447. PMID: 21786076. PMCID: PMC3362044.

13. Robertson K, Jiang H, Kumwenda J, Supparatpinyo K, Evans S, Campbell T, Price R, Tripathy S, Kumarasamy N, La Rosa A, et al. Improved Neuropsychological and Neurological Functioning Across Three Antiretroviral Regimens in Diverse Resource-Limited Settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study. Clin Infect Dis. 2012;55(6):868-76. PMID: 22661489. PMCID: PMC3491853.

14. Soria J, Bull M, Mitchell C, La Rosa A, et.al. Transmitted HIV resistance to first-line antiretroviral therapy in Lima, Peru. AIDS Res Hum Retroviruses. 2012; 28(4):333-8. PMID: 21819256. PMCID: PMC3316114.

1 R01 AI071212-01A1 (Frenkel) 04/01/06 to 03/31/11
NIH
"Mechanism / predictors of genital / rectal HIV shedding during ART w / plasma <50c/mL"
By characterizing the viral load in the blood genetics, genital tract and rectum through time, this study aims to determine the rate of excretion discordant plasma virus in the blood and genital tract / Rectal, determine epidemiological factors associated with discordant change and provide a greater understanding of the pathogenesis of virus expression activation of latent provirus entire front of replication cycles with the selection of drug-resistant viruses
Role: Co-Principal Investigator

Impacta believes that the benefits of alliances, affiliations and linkages with strategic partners translate into advantages and opportunities that contribute positively to the realization of a more effective job.
In Peru, Impact has the support of organizations such as:

Internationally, Impact has links with the National Institutes of Health in the United States, through agencies such as:

Since 2000, the pluripotent and multidimensional IMPACTA PERU Clinical Trials Unit (CTU) has established a comprehensive infrastructure and developed an experience research team able to support the implementation of basic and clinical research studies from the Peruvian government, US National Institutes of Health (US NIH), international funding and aid agencies and pharmaceutical industry, to rapidly respond to evolving research opportunities.

In particular, the IMPACTA PERU CTU has contributed to the development and implementation of the US NIH / National Institute of Allergy and Infectious Diseases HIV/AIDS scientific agenda by participating in the:  

• HIV Prevention Trials Network (http://www.hptn.org/)
• HIV Vaccine Trials Network (http://www.hvtn.org/)
• Microbicides Trials Network (http://www.mtnstopshiv.org/)
• AIDS Clinical Trials Group (https://actgnetwork.org/)
• International Network for Strategic Initiatives in Global HIV Trials (http://insight.ccbr.umn.edu/)

The IMPACTA PERU CTU is led Dr. Jorge Sanchez, MD, MPH and supported by a cadre of experienced researchers and promising junior investigators.  It has effectively utilized its intellectual and structural resources to create innovative tools for more efficient and creative operations in support of evolving scientific research agenda.  

The organizational structure of the IMPACTA PERU Clinical Trials Unit (CTU) has evolved building on the lessons learned since its conception into a three dimensional matrix in response to the increasing number and complexity of studies.

This structure provides clear lines of authority (Figure 1) to ensure cohesive functioning of IMPACTA PERU CTU components with integration across three dimensions that interact in a 3D matrix structure (Figure 2).

Figure 1. - 2D Structure

The matrix interplay promotes efficient utilization of infrastructure and resources, avoiding redundancies, sharing strategies and optimizing cost containment. This structure has proven to be flexible and able to accommodate multiple projects from different networks at two pluripotent clinical research sites, and to be able to rapidly respond to the needs of larger and/or more complex studies, including the integration of new sites when needed.

Figure 2 .- 3D Structure 

The three organizational dimensions include the organizational functions (in green), the support functions (in light blue) and the production functions (in different colors representing different sponsors). The success of the 3D matrix structure hinges on an organizational culture based on common goals, proactive problem solving, and search of synergisms across all IMPACTA PERU CTU components, enhancing creativity and innovation. Clear communication channels are outlined and standard operating procedures define who performs which tasks.

Administrative Area

It supports researchers by acting as a liaison with the IMPACTA administration.  It is responsible for budget oversight, financial reporting, management of consortium agreements, personnel hiring, program and project execution, resources sharing and cost containment.

Biostatistics, Informatics, Data Management and Systems

It is responsible for implementing and reviewing the Data Quality Management Plan, providing the IMPACTA PERU CTU-Enterprise System support, information technology support, biostatistics support, and training and supervising of data managers. 

 More details of the CTU-ES platform developed by this Resource Unit in this link

It is responsible for overseeing proper and timely regulatory submissions, site establishment, protocol registration, and site activation.  

Also provides the research staff with continue training on good clinical practices, human subjects protection, source documentation, essential documentation, storage and retention of clinical research records, standard operating procedures, and study specific procedures. Also, implements the Clinical Quality Management Plan and the Pharmacy Quality Management Plan.

It is responsible for performing assays in compliance with good clinical laboratory practices, Peruvian and U.S. National Institutes of Health laboratory guidelines, tracking specimen storage using Laboratory Data Management System®, shipping samples in compliance with International Air Transport Association regulations, developing and implementing the Laboratory Quality Management Plan, and maintaining proficiency testing certification.

It promotes community engagement in IMPACTA science generation and research implementation.  It is responsible for developing and implementing the Community Engagement and Community Education Plans, convening and supporting the Community Advisory Board, training staff personnel in good participatory practice, developing and implementing the Recruitment and Retention Plans.  

Also, it produces education and communication materials, manages social networking, and engages stakeholders.

IMPACTA has two clinical research sites (CRSs) fully equipped to conduct clinical trials and compliance with Peruvian and U.S. Federal regulations.  

They are conveniently located in Lima (a city with more than nine million inhabitants) to allow easy access to populations from different geographic areas, but comparable in terms of education, race, age and other demographic characteristics.

HIV Prevention

A. Concluded

A.1. HIV Vaccine Trials Network

1. HVTN 914. A cohort study in Lima, Peru to evaluate the feasibility of measuring immune responses and activation levels in the foreskin and rectosigmoid mucosa in HIV-negative, uncircumcised men who have sex with men and who are at high risk for HIV acquisition.

This was a single site, exploratory cohort study to assess the feasibility of performing safe and tolerable circumcision and rectosigmoid biopsy studies among HIV-seronegative, uncircumcised high-risk young men who have sex with men in Lima, Peru, assess institutional capacities to process mucosal samples and identify methods of evaluating foreskin and rectosigmoid mucosal immune responses that provide minimal variability for analysis of small sample sizes.  Data is being analyzed.

2. HVTN 905-2.  Collection of specimens from peripheral blood among male vaccinee responders in HVTN 502/Merck 023 and HVTN 050/Merck 018 of the Merck Ad5-vector vaccines.

This was a study with a single time point collection of specimens from peripheral blood to include participants from HVTN 502/Merck 023 and HVTN 050/Merck 018 who responded to the Merck Ad5 vaccines to conducted in-depth assessments of adaptive immune responses to the Merck trivalent Ad5 HIV vaccine in the systemic circulation.  The study found higher frequencies of pre-immunization adenovirus-specific CD4+ T cells were associated with substantially decreased magnitude of HIV-specific CD4+ T cell responses and decreased breadth of HIV-specific CD8+ T cell responses in vaccine recipients, independent of type-specific preexisting Ad5-specific neutralizing antibody titers.  Findings suggest that preexisting viral immunity may impact the efficacy of vaccines under current evaluation for prevention of HIV, tuberculosis, and malaria.

http://www.ncbi.nlm.nih.gov/pubmed/22201684 

A.2. Funded by the diverse mechanisms of the U.S. National Institutes of Health

1. University of Washington Center for AIDS Research 2010 Pilot Award.  Implementation of polarized HIV infections with foreskin tissue explants.

This was a laboratory-based study to test the feasibility of carrying out polarized explant infections with HIV, using fresh and frozen foreskin samples from Peruvian men.  Data is being analyzed.

2. University of Washington Center for AIDS Research 2011 New Investigator Award. B cell responses at the foreskin.

This was a laboratory-based study to test the hypothesis that humoral surveillance at the foreskin mucosa from men participating in HVTN 914, relies on transudation of systemic antibodies, and not on antibody secretion carried out by B cells at the site.  Data is being analyzed.

HIV Treatment

A. Concluded

B. Ongoing

B.1. AIDS Clinical Trials Group

1. A5243.  Plan for Obtaining Human Biological Samples at Non-U.S. Clinical Research Sites for Currently Unspecified Genetic Analyses

This non-randomized, multi-center protocol is designed to collect saliva and whole blood samples from participants in ACTG studies being conducted at non-U.S. clinical research sites. These samples will be used as a source of human DNA for currently unspecified genetic analyses.

2. A5271.  Collection of Comparison Neurocognitive Data in Resource-Limited Settings

This is a two-step prospective, observational, multinational study to collect comparative neurocognitive data for application to other studies. Neurologically healthy HIV-seronegative individuals from resource-limited settings will be enrolled.  Participants will have a baseline neuropsychological assessment performed, and a subset of participants will have a second visit in 6 months.

HIV Treatment

A. Concluded

A.1. AIDS Clinical Trials Group

1. A5227.  The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-“Nearly Naïve” Participants.

This was a single arm study to assess the virologic response to emtricitabine/tenofovir disoproxil fumarate plus efavirenz as treatment among women who had transient exposure to combination antiretrovirals for the HIV prevention-of-mother-to-child-transmission. Women were enrolled if they had no evidence of nucleoside reverse transcriptase inhibitors or non-nucleoside reverse transcriptase inhibitors resistance mutations on routine bulk viral population genotypic resistance testing. Data is being analyzed.  

http://clinicaltrials.gov/show/NCT00442962 

B. Ongoing

B.1. Funded by the pharmaceutical industry

1. VIOLIN.  An open-label study to evaluate the safety, tolerability and pharmacokinetics of etravirine (ETR) in combination with other antiretrovirals (ARVs) in antiretroviral treatment-experienced HIV-1 infected subjects.

This is an open-label, single arm, multicenter Phase 4 study to evaluate the safety, tolerability, and pharmacokinetics of etravirine (ETR) in combination with antiretroviral (ARV) therapy other than darunavir + ritonavir. In addition, the antiviral activity and the pharmacokinetic/pharmacodynamic profile, and safety of ETR will be assessed.  

http://clinicaltrials.gov/show/NCT01422330

HIV Prevention

A. Concluded

A.1. HIV Prevention Trials Network

1. HPTN 039.  A Phase III, randomized, double-blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among high risk HSV-2 seropositive, HIV-seronegative individuals.

This was a Phase III, multi-site, randomized, double-blind, placebo-controlled 2-arm trial of daily oral suppressive acyclovir therapy to prevent HIV acquisition among high risk HIV-uninfected, HSV-2 positive women and men who have sex with men (MSM).  The study showed that suppressive therapy with standard doses of aciclovir was not effective in reduction of HIV-1 acquisition in HSV-2 seropositive women and MSM, but decreased the incidence of genital ulcer on examination by 63%.

http://www.ncbi.nlm.nih.gov/pubmed/18572080  

A.2. HIV Vaccine Trials Network

1. HVTN 026.  A multisite Phase II clinical trial to evaluate the immunogenicity and safety of ALVAC-HIV vCP1452 alone and combined with MN rgp120.

The primary goal of this vaccine trial was to define the immunogenicity and confirm the safety of what was considered at that time, the best vector-based vaccine (ALVAC-HIV vector vCP1452) alone and in combination with a purified recombinant envelope protein vaccine (MN rgp120) with an established safety and immunogenicity profile.  In this study, both vaccines were well tolerated, and neutralizing antibody to the laboratory-adapted MN strain was detected. Cellular immune responses, as measured by CTL, ELISpot, and LPA, did not differ between vaccines and placebos.

http://www.ncbi.nlm.nih.gov/pubmed/17693888  

2. Merck V520 Protocol 018/HVTN 050.  A worldwide, Phase I, dose-escalating study of the safety, tolerability, and immunogenicity of a 3-dose regimen of the MRKAd5 HIV-1 gag vaccine in healthy adults.

This was a multicenter, double-blind, randomized, placebo-controlled study in healthy adults 18 to 50 years of age to assess the safety, tolerability and immunogenicity of a 3-dose regimen of the MRKAd5 HIV-1 gag vaccine at two different concentrations (1 x 109 vs. 1 x 1010 viral particles per dose).  The vaccine was well tolerated. Overall, responses to 1 × 1010 viral particles were 85% and 68% in subjects with low (≤200) and high (>200) baseline Ad5 titers, respectively.  The vaccine was immunogenic in diverse geographic regions, even in subjects from regions with high prevalence of preexisting Ad5 immunity.

http://www.ncbi.nlm.nih.gov/pubmed/20854108   

3. Merck V520 Protocol 023/HVTN 502.  A multicenter, double-blind, randomized, placebo-controlled Phase II proof-of-concept study to evaluate the safety and efficacy of a 3-dose regimen of the Merck Adenovirus Serotype 5 HIV-1 Vaccine gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) in adults at high risk of HIV-1 infection.

This is was a multicenter, randomized, double-blind placebo-controlled study conducted among high-risk adult volunteers, to assess the safety, tolerability and efficacy of the MRKAd5 HIV-1 gag/pol/nef vaccine in reducing the incidence of HIV-1 infection and/or among individuals who become infected with HIV, decrease the HIV-1 viral load set-point.  The vaccine did not prevent HIV-1 infection or reduce early viral load.  In exploratory analyses of all study volunteers, irrespective of baseline Ad5 antibody titre, the hazard ratio (HR) of HIV-1 infection between vaccine and placebo recipients was higher in Ad5 seropositive men (HR 2.3 [95% CI 1.2-4.3]) and uncircumcised men (3.8 [1.5-9.3]), but was not increased in Ad5 seronegative (1.0 [0.5-1.9]) or circumcised (1.0 [0.6-1.7]) men.

http://www.ncbi.nlm.nih.gov/pubmed/19012954  

4. HVTN 205.  A phase 2a clinical trial to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of pGA2/JS7 DNA and MVA/HIV62, in healthy, HIV uninfected vaccinia-naive adult participants.

This was a multicenter, randomized, controlled, double-blind trial to assess the safety, tolerability and immunogenicity of a prime-boost regimen of pGA2/JS7 DNA vaccine and MVA/HIV62 vaccine, in healthy, HIV-uninfected, vaccinia-naïve individuals.  Data is being analyzed.

http://clinicaltrials.gov/show/NCT00820846

5. HVTN 084. A randomized, double blind phase 1b trial to examine the influence of antigenic competition on the immunogenicity of HIV-1 Gag/Pol: A comparison of rAd5 gag/pol Env A/B/C to rAd5 gag/pol.  

This was a multicenter, randomized, double blind trial to determine whether the magnitude of T-cell responses to Gag and/or Pol is altered by co-immunization with Env, and determine whether the breadth of CD4+ and CD8+ T-cell responses to Gag and/or Pol is influenced by co-immunization with Env.  Data is being analyzed.

http://clinicaltrials.gov/show/NCT01159990 

A.3. Funded by the diverse mechanisms of the U.S. National Institutes of Health

1. Chemoprophylaxis for HIV prevention in men (iPrEx).  

This was a multicenter, randomized, double blind, placebo-controlled trial to determine if daily oral co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is safe and provides additional reduction in the incidence of HIV among men who have sex with men at high risk who receive standard HIV prevention interventions.  In this study, FTC/TDF showed a 44% reduction in the incidence of HIV (95% CI: 15-63; p=0.005).  Nausea was reported more frequently during the first 4 weeks in the FTC/TDF group than in the placebo group (p<0.001). The two groups had similar rates of serious adverse events (P=0.57).

http://www.ncbi.nlm.nih.gov/pubmed/21091279  

B. Ongoing

B.1. HIV Vaccine Trials Network

1. HVTN 102. A Phase 1b clinical trial to evaluate the safety and immunogenicity of different combinations of DNA-HIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX® B/E in healthy, HIV-1 uninfected adult participants.  

Under design.

B.2. Microbicides Trials Network

1. MTN 017. A Phase 2 randomized sequence open label expanded safety and acceptability study of oral emtricitabine/tenofovir disoproxil fumarate tablet and rectally-applied tenofovir reduced-glycerin 1% gel.

This is a Phase 2, multi-site, randomized, six-sequence, three-period, open label crossover study to evaluate and compare acceptability and compare the safety profiles of daily emtricitabine/tenofovir disoproxil fumarate tablet, daily tenofovir reduced-glycerin 1% gel, and receptive anal intercourse-associated tenofovir reduced-glycerin 1% gel, conducted among HIV-uninfected adult males or transgender females who practice receptive anal intercourse. 

http://clinicaltrials.gov/show/NCT01687218 

B.3. Funded by the diverse mechanisms of the U.S. National Institutes of Health

1. PUMA. Prevention Umbrella for MSM in the Americas

The long term goal of this research is to develop an optimal HIV prevention package for men who have sex with men (MSM) in the Americas and design a clinical study to evaluate the safety and efficacy of this package.  Different studies are being conducted to determine the feasibility and acceptability of the individual and combined components of the proposed package of prevention interventions among MSM in the Americas.

HIV Treatment

A. Concluded

A.1. AIDS Clinical Trials Group

1. A5175, A Phase IV, prospective, randomized, open-label evaluation of the efficacy of once-daily protease inhibitor and once-daily non-nucleoside reverse transcriptase inhibitor containing therapy combinations for initial treatment of HIV-1 infected individuals from resource-limited settings (PEARLS) trial.

This was a phase IV, randomized, open-label, three-arm antiviral efficacy trial designed to evaluate three antiretroviral regimens for treatment naïve HIV-infected participants.  Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) + efavirenz (EFV) had similar high efficacy compared to lamivudine/zidovudine + EFV in this trial population, recruited in diverse multinational settings.  Superior safety, especially in HIV-1-infected women, and once-daily dosing of FTC/TDF + EFV are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. Emtricitabine + didanosine + atazanavir had inferior efficacy and is not recommended as an initial antiretroviral regimen.

http://www.ncbi.nlm.nih.gov/pubmed/22936892

2. A5217. The SETPOINT Study - A randomized study of the effect of immediate treatment with potent antiretroviral therapy versus observation with treatment as indicated in newly infected HIV-1-infected subjects: Does early therapy alter the virologic setpoint?

This study randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretroviral therapy (immediate treatment [IT]) or no treatment (deferred treatment [DT]).  Patients were to start or restart ART if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log10 HIV-1 RNA level at week 72 (both groups) and 36 (DT group).  In this study, the IT group at week 72 had a better outcome than the DT group at week 72 (P = 0.005) and the DT group at week 36 (P = 0.002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group.  Progression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment.

http://www.ncbi.nlm.nih.gov/pubmed/22180621

3. A5221. STRIDE: A strategy study of immediate versus deferred initiation of antiretroviral therapy for AIDS disease-free survival in HIV-infected persons treated for tuberculosis with CD4 < 250 cells/mm3.

This was a randomized, open-label study to determine whether the strategy of immediate (within 2 weeks after the initiation of treatment for tuberculosis -TB) versus deferred (between 8 and 12 weeks after the initiation of treatment for TB) initiation of antiretroviral therapy (ART) reduces mortality and AIDS-defining events in participants being treated for tuberculosis.  Overall, earlier ART did not reduce the rate of new AIDS-defining illness and death by 48 weeks, as compared with later ART.  In persons with CD4+ T-cell counts of <50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. 

http://www.ncbi.nlm.nih.gov/pubmed/22010914

4. A5234. International trial of modified directly observed therapy versus self-administered therapy for participants with first virologic failure on a non-nucleoside reverse transcriptase inhibitor-containing antiretroviral regimen.

This was a multicenter trial in HIV-1 infected subjects failing their first NNRTI-based regimen. A total of 145 participants were treated with a protease inhibitor-based second line regimen and randomized to a modified directly observed therapy (mDOT) versus standard of care. The mDOT was provided under the supervision of a friend, partner or family member who witnessed at least one dose a day, at least 5 days a week for the first 24 weeks of therapy, and reported to the site when adherence problems were identified. IMPACTA sites were able to enroll 94 subjects/partners. Follow up has been completed and study results are being analyzed.

http://clinicaltrials.gov/show/NCT00608569 

A.2. The Community Programs for Clinical Research on AIDS

1. SMART. A large, simple trial comparing two strategies for management of anti-retroviral therapy (The SMART Study).

The SMART study randomly assigned persons infected with HIV who had a CD4+ cell count >350 per cubic millimeter to the continuous use of antiretroviral therapy –ART- (the viral suppression group) or the episodic use of ART (the drug conservation group). Episodic use involved the deferral of therapy until the CD4+ count decreased to <250 per cubic millimeter and then the use of therapy until the CD4+ count increased to >350 per cubic millimeter.  Episodic antiretroviral therapy guided by the CD4+ count, significantly increased the risk of opportunistic disease or death from any cause (3.3 events per 100 person-years) when compared with continuous antiretroviral therapy (1.3 events per 100 person-years). Hazard ratio for the drug conservation group vs. the viral suppression group, 2.6; 95% CI: 1.9-3.7; p<0.001). Adjustment for the latest CD4+ count and HIV RNA level (as time-updated covariates) reduced the HR for the occurrence of opportunistic disease or death from any cause occurred from 2.6 to 1.5 (95% CI: 1.0-2.1), suggesting that the increased risk was largely as a consequence of lowering the CD4+ cell count and increasing the viral load. 

http://www.ncbi.nlm.nih.gov/pubmed/17135583

A.3. Funded by the pharmaceutical industry

1. CASTLE.  A 96 week study comparing the antiviral efficacy and safety of atazanavir/ritonavir with lopinavir/ritonavir, each in combination with fixed dose tenofovir-emtricitabine in HIV-1 infected treatment in naive subjects.  

This was an open-label, international non-inferiority study, conducted among antiretroviral-naive, HIV-1-infected patients, who were randomly assigned to receive atazanavir/ritonavir (ATV/r) once daily or lopinavir/ritonavir (LPV/r) twice daily, in combination with fixed-dose tenofovir/emtricitabine once daily. ATV/r once-daily demonstrated similar antiviral efficacy to LPV/r twice-daily, with less gastrointestinal toxicity but with a higher rate of hyperbilirubinaemia.

http://www.ncbi.nlm.nih.gov/pubmed/18722869

2. STRMRK.  A multicenter, double-blind, randomized, active-controlled study to evaluate the safety and antiretroviral activity of MK-0518 versus efavirenz in treatment naive HIV-infected patients, each in combination with TRUVADA™.

This study compared the safety and efficacy of raltegravir (RAL) with efavirenz (EFV) as part of combination antiretroviral therapy for treatment-naive patients.  The time to achieve such viral suppression was shorter for patients on RAL than on EFV (log-rank test p<0.0001). RAL-based combination treatment had rapid and potent antiretroviral activity, which was non-inferior to that of EFV at week 48.  RAL is a well-tolerated alternative to EFV as part of a combination regimen against HIV-1 in treatment-naive patients.

http://www.ncbi.nlm.nih.gov/pubmed/19647866

3. SECOND LINE.  A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy.

The investigators hypothesized that following virological failure of a standard non-nucleoside reverse transcriptase inhibitor + two nucleosi(ti)de inhibitors [2N(T)RTIs] regimen, second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir (LPV/r) and 2N(T)RTIs will offer comparable efficacy to that provided by LPV/r and raltegravir.
The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks. Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life. The study is completed and data is under analysis.

http://clinicaltrials.gov/show/NCT00931463

B. Ongoing

B.1. AIDS Clinical Trials Group

1. A5225.  A Phase I/II dose-finding study of high-dose fluconazole treatment in AIDS-associated cryptococcal meningitis. 

This study will explore the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose fluconazole for management of cryptococcal meningitis in HIV-infected patients.

http://clinicaltrials.gov/show/NCT00885703

2. A5250. Durability of adherence in self-management of HIV.

This Phase 3 study will test a modified client adherence profiling and intervention tailoring (CAP-IT) intervention that helps people infected with HIV take all their medications when and how they are supposed to.

http://clinicaltrials.gov/show/NCT00991302

3. A5273.  Study of options for second-line effective combination therapy (SELECT).

The Phase 3 study will determine whether taking the combination of lopinavir/ritonavir (LPV/r) + raltegravir works as well as what usually is used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination.  Testing a regimen that does not include any NRTI is important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.

http://clinicaltrials.gov/show/NCT01352715

4. A5274.  Reducing early mortality and early morbidity by empiric tuberculosis treatment regimens (REMEMBER).

The purpose of this Phase 4 study is to test an experimental approach to tuberculosis (TB) treatment to see if it is better and safer than the usual approach.  The experimental approach is to start TB treatment at the same time as HIV treatment, even when TB infection has not been found.  The usual approach is to start TB treatment only if TB infection is found.  In this study, half of the people will start TB treatment at the same time as they start their HIV treatment. The other half will start TB treatment only if TB infection is found.  

http://clinicaltrials.gov/show/NCT01380080 

5. A5282.  A randomized trial to compare an HPV test-and-treat strategy to a cytology-based strategy for prevention of CIN 2+ in HIV-infected women.

This is a Phase 2 study comparing the efficacy, safety and tolerability of cervical cryotherapy and loop electrosurgical excision procedure (LEEP) to prevent cancer of the cervix in women who have HIV. 

http://clinicaltrials.gov/show/NCT01315353 

6. A5288.  Management using the latest technologies in resource-limited settings to optimize combination therapy after viral failure (MULTI-OCTAVE).

This is a Phase 4 study to test a strategy of using a resistance test to choose anti-HIV drugs for individuals who have failed to a second antiretroviral treatment regimen, and then evaluate the efficacy, safety and tolerability of combinations of new anti-HIV drugs to control HIV infection.

http://clinicaltrials.gov/show/NCT01641367 

7. PROMISE.  HAART standard version of the promoting maternal and infant survival everywhere (PROMISE) study.

This Phase 4 study will examine whether it is healthier for pregnant, HIV-infected women receiving highly active antiretroviral treatment (HAART) for HIV prevention of mother-to-child-transmission to continue or stop treatment, when HAART was initiated far above 350 CD4+ cell counts.

http://clinicaltrials.gov/show/NCT00955968 

B.2. International Network for Strategic Initiatives in Global HIV Trials

1. START.  Strategic timing of antiretroviral treatment.

This is a Phase IV, randomized trial to find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their CD4+ cell count is >500, instead of waiting until the CD4+ count is ≤350.  Also, this study will provide insight about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

http://clinicaltrials.gov/show/NCT00867048

B.3. Funded by the diverse mechanisms of the U.S. National Institutes of Health

1. SABES?

This is three-step study. Step 1 is screening men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing is being conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV are being tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.

http://clinicaltrials.gov/show/NCT01815580

2. AHORA

This study is recruiting HIV-infected men with alcohol use disorders. Men will be randomized to receive either extended release-naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment and be randomized to extended release-naltrexone or placebo. The purpose of this study is to see whether use of extended release-naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of extended release-naltrexone on alcohol use behaviors in this population.

http://clinicaltrials.gov/show/NCT01377168 

B.4. Funded by the pharmaceutical industry

1. GARDEL.  A Phase 3, randomized, open label, controlled study of lopinavir/ritonavir and lamivudine versus standard therapy in naïve HIV-1 infected subjects.

The purpose of this study is designed to compare the safety, tolerability, antiviral activity and immunological effect of lopinavir/ritonavir (LPV/r) plus lamivudine versus standard therapy with 2 nucleoside/nucleotide reverse transcriptase inhibitors plus LPV/r in the treatment of naïve HIV-1 infected subjects.

http://clinicaltrials.gov/show/NCT01237444 

2. AI438-011.  A Phase IIb randomized, controlled, partially-blinded trial to investigate safety, efficacy and dose-response of BMS-663068 in treatment-experienced HIV-1 subjects, followed by an open-label period on the recommended dose.

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068, a HIV attachment inhibitor with raltegravir (RAL) + tenofovir disoproxil fumarate (TDF).  At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects.

http://clinicaltrials.gov/show/NCT01384734 

3. I467-003.  A Phase IIb randomized, controlled, partially blinded clinical trial to investigate safety, efficacy and dose-response of BMS-986001 in treatment-naive HIV-1-infected subjects, followed by an open-label period on the recommended dose.

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with efavirenz + lamivudine for treatment-naive HIV-1 infected subjects.

http://clinicaltrials.gov/show/NCT01489046 

Sexually Transmitted Infection Treatment

A. Ongoing

A.1. Funded by the diverse mechanisms of the U.S. National Institutes of Health

1. Expedited partner therapy and sexually transmitted infection control for men who have sex with men in Peru

It is a randomized clinical trial to assess the impact of expedited partner therapy on partner notification and treatment among men who have sex with men diagnosed with gonorrhea or chlamydia. 

http://clinicaltrials.gov/show/NCT01720654

2. Partner notification strategies for HIV and sexually transmitted infection control in Peru

It is a randomized clinical trial to assess the efficacy of internet- and referral card-based partner notification tools for the improvement of partner notification outcomes among MSM in Lima, Peru. 

http://clinicaltrials.gov/show/NCT01720641 

Tuberculosis Prevention

A. Ongoing

A.1. AIDS Clinical Trials Group

1. A5259 [TBTC Study 26: Effectiveness and tolerability of weekly rifapentine/isoniazid for 3 months versus daily isoniazid for 9 months for the treatment of latent tuberculosis infection].

It is an open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose) regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).  The use of weekly 3RPT/INH for 3 months was as effective as daily 9INH alone in preventing tuberculosis and had a higher treatment-completion rate among HIV negative individuals.  Specific information from HIV positive individuals was not able to be assessed given the lower number of volunteers enrolled by the time the efficacy of the study was assessed.  A5279 will complement information about the effectiveness and tolerability of the intervention among HIV positive individuals.

http://www.ncbi.nlm.nih.gov/pubmed/22150035

2. A5279.  Evaluating the safety and effectiveness of short-course rifapentine/isoniazid for the prevention of active tuberculosis in HIV-infected individuals with latent tuberculosis infection.

HIV-infected people have an increased risk of developing active tuberculosis (TB). The standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of treatment may be as effective and potentially increase treatment adherence. This study will compare the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

http://clinicaltrials.gov/show/NCT01404312 

HIV Diagnosis

A. Concluded

A.1. Funded by the pharmaceutical industry

1. Reproducibility of the COBAS Taqman HIV-1 test.

It was a study to evaluate the reproducibility of the COBAS Taqman HIV-1 test, version 2.0 for use with the High Pure System.

Tuberculosis Diagnosis

A. Concluded

A.1. AIDS Clinical Trials Network

1. A5253. Sensitivity and specificity of Mycobacterium tuberculosis screening and diagnostics in HIV-infected individuals.

In an observational, multi-country, cross-sectional study of HIV-infected patients, a standardized diagnostic evaluation (SDE) for TB, intended to provide an increase in identification of participants with active pulmonary TB without sacrificing specificity, was compared to standard of care (SOC).  SOC evaluations included TB symptom review (current cough, fever, night sweats and/or weight loss), sputum Ziehl-Neelsen staining and chest radiography.  SDE screening added extended clinical signs and symptoms and fluorescent microscopy (FM).  In this study, SOC screening had 54% sensitivity (95%CI 40-67) and 76% specificity (95%CI 72-80). Positive and negative predictive values were respectively 24% and 92%. No elements of the SDE improved the predictive values of SOC.  This suggested that symptom-based screening with smear microscopy was insufficiently sensitive and that more sensitive diagnostic testing is required for HIV-infected patients.

http://www.ncbi.nlm.nih.gov/pubmed/23485388

2. A5255. Faster AFB identification, speciation of TB, and evaluation of drug resistance in HIV-infected persons initiating TB treatment.

This study was conducted to know whether some new tests for identifying tuberculosis (TB) and for identifying resistance to TB drugs are at least as accurate as the current testing methods when used on HIV-infected individuals. The study also assessed whether the new tests can provide accurate results faster than the current methods.  This study is concluded, and data is being analyzed for report.

http://clinicaltrials.gov/show/NCT00959088 

B. Epidemiological and Behavioral Studies

C. Outcomes Research

HIV Prevention

A. Concluded

A.1. HIV Prevention Trials Network

1. HPTN 036. HIV prevalence, incidence and HSV-2 prevalence among high-risk MSM in Lima, Peru. 

This study was conducted to provide biomedical and behavioral data for the planning and implementation of HIV prevention trials in Lima.  The study aimed to determine the prevalence, incidence, and risk factors for syphilis, HSV-2, and HIV among high-risk HIV-uninfected men who have sex with men, and among HSV-2 seropositive men, evaluate informed consent procedures, eligibility criteria, and willingness to participate in a trial of daily suppressive acyclovir for HIV prevention; as well as, to identify effective follow-up strategies for high-risk men who have sex with men in Lima to achieve at least 90% retention at 12 months.

http://clinicaltrials.gov/show/NCT00023582 

2. HPTN 039-01-Ancillary: Prospective cohort study of HPTN 039 seroconverters: The effect of HSV-2 suppression on HIV-1 viral set point.

This was a prospective multi-site cohort study to determine the effect of HSV-2 suppression with twice-daily acyclovir during the first six months after HIV acquisition on HIV viral set point.  Women and men who have sex with men enrolled in the randomized-controlled trial of acyclovir in the reduction of HIV acquisition (HPTN 039) who are identified as HIV-positive during follow-up participated in this study. The study found no significant difference in plasma HIV-1 RNA levels (P =.30) or CD4 cell counts (P =.85) between the acyclovir and placebo recipients. Acyclovir suppression during HIV-1 seroconversion and the subsequent 6 months does not affect HIV-1 set point.

http://www.ncbi.nlm.nih.gov/pubmed/20649426  

A.2. HIV Vaccine Trials Network

1. HVTN 403.  A multi-site evaluation of virologic, immunologic, and clinical natural history of participants enrolled in Phase I and Phase II HIV vaccine protocols or HIV vaccine preparedness cohorts who develop HIV infection subsequent to trial enrollment.

This study was a multisite, observational, prospective cohort study of participants enrolled as soon as possible after confirmation of HIV infection subsequent to receiving candidate or placebo vaccines in AIDS Vaccine Evaluation Group or HVTN Phase 1 and 2 HIV vaccine trials.

2. HVTN 504.  Observational follow-up of adult participants enrolled in the Step Study (Merck V520 Protocol 023/HVTN 502), a 3-dose regimen of the Merck MRK Ad5 HIV-1 gag/pol/nef vaccine or placebo.

This was a multicenter, observational research study conducted among vaccinees and placebo recipients of the Step Study (Merck V520 Protocol 023/HVTN 502), to assess the relative incidence of HIV infection over time, and assess and compare pre-antiretroviral treatment viral loads in individuals who become infected with HIV.

http://www.ncbi.nlm.nih.gov/pubmed/22561365

A.3. AIDS Clinical Trials Group

1. A5199.  International neurological study: A stand-alone study for participants of A5175 (A Phase IV, randomized, open-label evaluation of the efficacy of once-daily protease inhibitor and once-daily non-nucleoside reverse transcriptase inhibitor-containing therapy combination for Initial treatment of HIV-1 infected individuals from diverse areas of the world).

Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however, the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that as many as 40% of patients with HIV develop some form of dementia. The study detected no significant differences in neuropsychological and neurological outcomes between randomized ART regimens. Significant improvement occurred in neurocognitive and neurological functioning over time after initiation of antiretroviral treatment.  The etiology of these improvements is likely multifactorial, reflecting reduced central nervous system HIV infection, better general health, and practice effects. This study suggests that treatment with either of the World Health Organization -recommended first-line antiretroviral regimens in resource-limited settings will improve neuropsychological functioning and reduce neurological dysfunction.

http://www.ncbi.nlm.nih.gov/pubmed/22661489

B. Ongoing

B.1. HIV Vaccine Trials Network

1. HVTN 404.  Long-term follow-up of HIV-1 infection in participants who become infected after enrollment in early-phase (phase 1 and 2a) HIV vaccine protocols or HIV vaccine preparedness cohorts.

This is a multisite, observational, prospective cohort study evaluating the disease progression of participants who become HIV-1 infected after enrollment in HVTN, AIDS Vaccine Evaluation Group (AVEG), or HIV Network for Prevention Trials (HIVNET) early phase (Phase 1 or 2a) vaccine trials or HVTN vaccine preparedness trial.

2. HVTN 802.  A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials.

This is a multi-site, nonrandomized, observational, and descriptive study evaluating the clinical, virologic, and immunologic course of HIV-1 infection among participants who become infected with HIV-1 after enrollment in HIV-1 vaccine trials in which HIV-1 infection constitutes an endpoint.

3. HVTN 910.  A protocol to assess the persistence of HIV vaccine-induced seropositivity in participants who received vaccine in DAIDS-funded preventive HIV vaccine trials.

This is a multicenter observational study to describe how long vaccine-induced antibodies to HIV, detectable on commercially available HIV antibody (Ab) test kits, persist in HIV-uninfected participants who have received preventive HIV vaccines.

A.4. Health Services Research

Biography

During the past 10 years, after graduating from Internal Medicine, Infectious Diseases and HIV-AIDS specialty training in the USA, I have conducted clinical research in Peru, with projects focused on treatment of HIV/AIDS. Most of this clinical research has been within the AIDS Clinical Trials Group (ACTG) and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), both funded by the Division of AIDS of the NIAID. I am currently the Investigator of Record for several ACTG clinical trials that includes A5259, A5288, A5271, A5234, and the START funded by the research network INSIGHT.
I endorse this application for the IMPACTA PERU Clinical Trials Unit and commit to serve as an Investigator of the San Miguel CRS 11302.

Positions and Honors

Selected peer-reviewed publications 

1. Terashima A, Gotuzzo E, Alvarez H, Infante R, Tello R, Watts D, Freedman D. Strongyloides stercoralis: clinical severe forms associated to HTLV-1 infection. Rev Gastroenterol Peru. 1999;19(1):35-40. PMID: 12177707.

2. Gotuzzo E, Terashima A, Alvarez H, Tello R, Infante R, Watts DM, Freedman DO. Strongyloides stercoralis hyperinfection associated with human T cell lymphotropic virus type-1 infection in Peru. Am J Trop Med Hyg. 1999;60(1):146-9. PMID: 9988339.

3. Terashima A, Alvarez H, Tello R, Infante R, Freedman D, Gotuzzo E. Treatment failure of intestinal strongyloidiasis: an indicator of HTLV-1 infection. Int J Infect Dis. 2002;6(1):28-30. PMID: 12044298.

4. Infante RM, Ericsson CD, Jiang ZD, Ke S, Steffen R, Riopel L, Sack DA, DuPont HL. Enteroaggregative Escherichia coli (EAEC) Diarrhea in Travelers: Response to Rifaximin Therapy. Clin Gastroenterol Hepatol. 2004;2(2):135-8. PMID: 15017618.

5. Han X, Tarrand I, Infante R, Jacobson K, Truong M. Clinical Significance and Epidemiologic Analyses of Mycobacterium avium and Mycobacterium intracellulare among Patients without AIDS. Journal of Clinical Microbiol. 2005;43(9):4407-12. PMID: 16145084. PMCID: PMC1234053.

Ongoing Research Support

1 UM1 AI 069438-07 (Sanchez) 12/01/2012 – 11/30/2013
NIH
The IMPACTA PERU Clinical Trials Unit
To evaluate HIV vaccine candidates, prophylaxis, and optimization of antiretroviral treatment, and to reduce HIV risky behaviors.
Role: IoR

1 UO1 AI068641 (Neaton) 06/29/2006 – 05/31/2013
NIH
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
TO3: Strategic Timing of Antirretroviral Therapy (START)
TO4: FLU002 and FLU003 studies.
Role: IoR

Biography

I hold a BS in Medicine (1997) and an MD (1998) from Universidad Peruana Cayetano Heredia, Lima, Peru. I hold a master in Clinical Research from the University California San Francisco. I joined Asociacion Civil Impacta Salud y Educacion in 2004 and have participated in several clinical trials as Co-Investigator and Investigator of Record for the HIV Prevention Trial Network (HPTN), the HIV Vaccine trial Network (HVTN), the AIDS Clinical Trial Group (ACTG), the Microbicides Trial Network (MTN), and INSIGHT.  I am currently the Site Principal Investigator for the MTN 017 and for the Randomized Placebo-Controlled Clinical Trial to Assess the Impact of Extended-Release Naltrexone on HIV Treatment Outcomes AmongHIV-1 infected Men Who Have Sex with Men and Transgender Women with Alcohol Use Disorders in Lima, Peru. I was a member of the Network Evaluation committee of the HVTN and a member of the Site Management and Clinical Care and the Translational and Drug Development Committees, both from the ACTG research network.

Since 2011, I am the head of the Clinical Research Resource Unit (RU). I am responsible for the implementation and annual review of the CQMP, which includes, but is not limited to: a) development of sound processes and procedures to provide quality assurance steps and periodic assessments to ensure and verify compliance with requirements b) the development of tools to generate trial QC/QA indicators (including review of informed consent form and processes, eligibility criteria, scheduled/missed visits, protocol test and procedures, concomitant/prohibited medications, study product administration, identification and reporting of serious adverse events); c) ensure that contents of regulatory files are complete and current; d) determine the frequency and types of QC/QA activities; e) review documented CQMP activities; f) prepare quarterly report to be submitted to the CGC; g) supervise the Pharmacy QC/QA Officer; and h) prepare the annual CQMP annual report. I am fully committed to serve as the San Miguel CRS Coordinator and also the head of the Clinical Research RU of the IMPACTA Peru CTU.

Positions and Honors

Research Positions

Experience and Professional Memberships

Completed Research Support

U01 AI064002 - (Grant) 08.15.05 hasta 01.31.11
EE.UU. NIH / NIAID
"Quimioprofilaxis para la Prevención del VIH en Hombres peruanos"
Rol: IoR de estudio DEXA

Biography

I am a medical doctor and a specialist in Statistics for Research, with a master degree in Social Projects and Programs from Universidad Peruana Cayetano Heredia, Peru. I hold a master degree in Biomedical and Health Informatics from the University of Washington (UW) and since 2009 I am affiliate assistant professor of the Department of Global Health at UW.  Since 2006, I am the head of the Biostatistics, Informatics, Data Management, and System Resource Unit of the IMPACTA Peru Clinical Trials Unit (CTU).

The BIDS RU is responsible for a) fostering proper and timely regulatory approval (See section 9.1); b) ensuring implementation of the Clinical Quality Management Plan (See Section 9.3); c) enforcing compliance with SOP and Study Specific Procedures (SSP) in coordination with other RUs; d) training CTU and CRS personnel in GCP, HSP, Source Documentation, SSP and other areas (See Section 9.4); e) fulfilling requirements for site establishments, protocol registration and protocol activation, and site registration and activation procedures; and f) developing and implementing the pharmacy quality management plan by the Pharmacy QA/QC Supervisor. I express my firmly commitment to the IMPACTA Peru CTU and will continue serving as the head of the BIDS RU of the IMPACTA Peru CTU.

Positions and Honors

Experience and Professional Memberships

Honors

Selected peer-reviewed publications 

1. Luy G, Maldonado G, Chinga E, Luy S, Peinado J. Clinic characteristics of the colorectal cancer in the Hospital E. Reblagliati Martins 1995-1999, Lima, Peru. Revista de Gastroenterologia del Peru. 20 (4) 2000.

2. Gotuzzo E, Peinado J, Tijero M, Mayorca C, Badajos A. Evaluation of a training program in sexual education and AIDS for teachers in the North of Lima, Peru. 1996-1997. Revista Medica Herediana 12(2), 2001.

3. Llanos Zavalaga LF, Contreras Rios CE, Velasquez Hurtado JE, Mayca Perez JA, Lecca Garcia Leonid, Reyes Lecca R, Peinado J. Auto medication in five provinces from Cajamarca, Peru. Rev Med Hered 2001;12:127-133.

4. Peinado J, Erick Chinga Alayo, Daniel Mendoza Requena, Angel Rosas Aguirre, Enrique Velásquez Hurtado, Carmen Nasarre, Fernando Llanos-Zavalaga. Uso del sistema de información geográfica para determinar la relación entre la severidad de la crisis Asmáticas en niños y la cercanía a fábricas con chimenea en un distrito de lima – Perú Rev Peru Med Exp Salud Publica 2002; 19(3).

5. Peinado J. Lematization of complex medical words: An implemented in LISP. Rev Med Hered 2003, 14(4).

6. Zunt JR, La Rosa A, Peinado J, Montano SM, Chauca G, Lama JR, Suarez L, Sanchez JL. Risk factors for HTLV-II infection in Peruvian men who have sex with men. Am J Trop Med Hyg. 2006;74(5):922-5. PMID: 16687704.

7. Goodreau SM, Peinado J, Goicochea P, Vergara J, Ojeda N, Casapia M, Ortiz A, Zamalloa V, Galvan R, and Sanchez JR 2007. Role versatility among men who have sex with men in urban Peru, J Sex Res. 2007; 44(3):233-9. PMID: 17879166.

8. Sanchez J, Lama JR, Peinado J, Paredes A, Lucchetti A, Russell K, Kochel T, Sebastian JL. High HIV and ulcerative sexually transmitted infection Incidence estimates among men who have sex with men in Peru: awaiting for an effective preventive intervention. J Acquir Immune Defic Syndr. 2009;51 Suppl 1:S47-51. PMID: 19384102.

9. La Rosa AM, Zunt JR, Peinado J, Lama JR, Ton TG, Suarez L, Pun M, Cabezas C, Sanchez J, for the Peruvian HIV Sentinel Surveillance Working Group. Retroviral infection in Peruvian men who have sex with men. Clin Infect Dis. 2009;49(1):112–7. PMID: 19480577.

10. Peinado J. Economy and science behind the use of medical abbreviations in health records. Rev. peru. epidemiol. Vol 13 No 1 April 2009.

11. Curioso WH, Peinado J, Rubio CF, Lazo-Escalante M, Castagnetto JM. Biomedical and health informatics in Peru: significance for public health. Health Info Libr J. 2009;26(3):246-51. PMID: 19712217.

12. WH Belloso, LC Orellana, B Grinsztejn, JS Madero, A La Rosa, VG Veloso, Sanchez J, R Ismerio Moreira, B Crabtree-Ramirez, O Garcia Messina, MB Lasala, Peinado J, and MH Losso. Analysis of serious non-AIDS events among HIV-infected adults at Latin American sites. HIV Med. 2010; 11(9):554-64. PMID: 20345879.

13. Kinsler JJ, Galea JT, Peinado J, Segura P, Montano SM, and Sanchez L. Lubricant use among men who have sex with men reporting receptive anal intercourse in Peru: implications for rectal microbicides as an HIV prevention strategy. Int J STD AIDS. 2010;21(8):567-72. PMID: 20975090.

14. Jacob ST, Baeten JM, Hughes JP, Peinado J, Wang J, Sanchez J, Reid SE, Delany- Moretlwe S, Cowan F, Fuchs J, Koblin B, Griffith S, Wald A, Celum C for the HPTN 039 Protocol Team. A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial. AIDS Behav. 2011; 15(5):897-904. PMID: 21104007.

15. Kinsler JJ, Galea JT, Lama J, Segura P, Peinado J, Casapia M, Ortiz A, Nadjat-Haiem, Montano SM, Sanchez J. Rectal douching among Peruvian men who have sex with men, and acceptability of a douche-formulated rectal microbicide to prevent HIV infection. Sex Transm Infect. 2012. [Epub ahead of print]. PMID: 22773324.

Completed Research Support 

5 D43 TW008069-02 (Sanchez) 04/01/09– 03/31/11
A Step Forward for Latin American AIDS Research and Training Program (LAARTP)
To establish a curriculum on HIV/AIDS in order to provide specialized training on clinical research in the Latin American region
Role: Study Coordinator

U01 AI064002 – (Grant) 08/15/05 – 01/31/11
US NIH/NIAID
“Chemoprophylaxis for HIV Prevention in Peruvian Men”
Role: CASI Working Group 

Biography

I graduated as nurse at Universidad del Callao, Peru (1993), and hold a MPH degree from the University of Washington (2004). I have served as the National Coordinator for the peer-educator intervention on female sex workers (FSW) at the National AIDS and STD Control Program, and as the study coordinator for the FSW intervention component of an urban community randomized trial of sexually transmitted disease prevention. Since joining IMPACTA in 2005, I have been the study coordinator for two DAIDS funded studies. Since 2011, I am the Co-Chair for the Global Community Educators and Recruiters working group at the HVTN, and in 2012, I became member of MTN Community Working Group.

In 2008, I assumed the position of Head of the Community Education and Engagement RU and Community Educator for the IMPACTA Clinical Trials Units (IMPACTA CTU). My responsibilities include a) developing and implementing the Community Engagement and Community Education plans; b) convening and providing support to the CAB; c) developing and implementing the Recruitment and Retention Plan; d) overseeing the production of information, education and communication materials; d) managing social network campaigns to promote community participation; f) reaching stakeholders and media to advocate in favor of research participation; g) preparing reports to the CGC and the networks; and h) training staff personnel in Good Participatory Practice. I express my commitment to continue serving as the head of the Community Education and Engagement RU for the IMPACTA CTU.

Positions and Honors

Experience and Professional Memberships

Selected peer-reviewed publications 

1. Kurth AE, Curioso WH, Ngugi E, McClelland L, Segura P, Cabello R, Berry DL. Personal digital assistants for HIV treatment adherence, safer sex behavior support, and provider training in resource-constrained settings. AMIA Annu Symp Proc. 2007:1018. PMID: 18694116.

2. Curioso WH, Kurth AE, Cabello R, Segura P, Berry DL. Usability evaluation of personal digital assistants (PDAs) to support HIV treatment adherence and safer sex behavior in Peru. AMIA Annu Symp Proc. 2008:918. PMID: 18999317.

3. Curioso WH, Kepka D, Cabello R, Segura P, Kurth AE. Understanding the facilitators and barriers of antiretroviral adherence in Peru: a qualitative study. BMC Public Health. 2010;10:13. PMID: 20070889. PMCID: PMC2820472.

4. Gomez GB, Campos PE, Buendia C, Carcamo CP, Garcia PJ, Segura P, Whittington WL, Hughes JP, Ward H, Garnett GP, Holmes KK. Studying complex interactions among determinants of healthcare-seeking behaviours: self-medication for sexually transmitted infection symptoms in female sex workers. Sex. Transm. Infect. 2010;86(4):285-91. PMID: 20660592.

5. Kinsler JJ, Galea JT, Peinado J, Segura P, Montano SM, and Sanchez L. Lubricant use among men who have sex with men reporting receptive anal intercourse in Peru: implications for rectal microbicides as an HIV prevention strategy. Int J STD AIDS. 2010;21(8):567-72. PMID: 20975090.

6. Kinsler JJ, Galea JT, Lama J, Segura P, Peinado J, Casapia M, Ortiz A, Nadjat-Haiem, Montano SM, Sanchez J. Rectal douching among Peruvian men who have sex with men, and acceptability of a douche-formulated rectal microbicide to prevent HIV infection. Sex Transm Infect. 2012. [Epub ahead of print]. PMID: 22773324.

Completed Research Support

US Naval Medical Research Center - NMRCD.2007.0021 01/2008 – 12/2011
NIH – Fogarty International Center
Epidemiology of HIV in Latin American Countries
Goal: To determine the prevalence of HIV infection and other viral sexually transmitted infections (STIs) such HTLV-I/II, HBV, herpes and syphilis in population groups in the region
Role: Co-investigator

Biography

I am medical doctor with a specialty on Pathology and Clinical Laboratory Medicine. As the Director of the Laboratory Research Resource Unit that comprises the IMPACTA Central lab, the San Miguel CRS Laboratory and the ACSA CRS laboratory, my responsibilities include: a) performing assays under Good Clinical Laboratory Practice (GCLP); b) tracking specimen storage using Laboratory Data Management System (LDMS®); c) shipping samples in compliance with International Air Transport Association (IATA) regulations; d) developing and implementing the Laboratory Quality Management Plan; e) maintaining current proficiency testing certification; and f) training laboratory staff in GCLP, IATA, Occupational Safety and Health Administration (OSHA), Biohazard Containment Training, and the LDMS training (when appropriate) . I express my fully commitment to the present proposal of the IMPACTA PERU Clinical Trials Unit as the head of the Laboratory Resource Unit.

Positions and Honors

Experience and Professional Memberships

Selected peer-reviewed publications 

1. Lama JR, Agurto HS, Guanira JV, Ganoza C, Casapia M, Ojeda N, Ortiz A, Zamalloa V, Suarez-Ognio L, Cabezas C, Sanchez JL, Sanchez J. Hepatitis B infection and association with other sexually transmitted infections among men who have sex with men in Peru. Am J Trop Med Hyg 2010; 83(1):194–200. PMID: 20595501. PMCID: PMC2912599.

2. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Eng J Med. 2010; 363(27):2587-99. PMID: 21091279. PMCID: PMC3079639.

Completed Research Support

U01 AI064002 – (Grant) 08/15/05 – 01/31/11
US NIH/NIAID
“Chemoprophylaxis for HIV Prevention in Peruvian Men”
Role: Lab Director

1 R01 AI071212-01A1 (Frenkel) 04/01/06-03/31/11
NIH
“Mechanism/predictors of genital/rectal HIV shedding during ART w/plasma <50c/mL”
By characterizing the viral load and genetics in blood, genital tract and rectum over time, this study aims to determine the rate of discordant shedding of virus in the blood plasma and genital tract/rectal; determine the epidemiological factors associated with discordant shedding; and provide further insight into the pathogenesis of expression of virus from activation of latent provirus versus full-cycles of replication with selection of drug-resistant virus
Role: Lab Director

Biography

From 2010 to 2011, I worked as clinical coordinator in for the HTLV-1 working group and collaborated with the HIV working group at the Instituto de Medicina Tropical Alexander von Humboldt of Universidad Peruana Cayetano Heredia. From September 2011 to December 2011, I was advisor of the Peruvian National STD and AIDS Control Program and gained experience in the coordination and monitoring of health policies on HIV/AIDS.

From January 2012 to August 2012, I worked as assistant physician in the Emergency Department of Hospital Nacional Cayetano Heredia. Currently, I am junior investigator at the Asociacion Civil Impacta Salud y Educacion. In addition, I am a clinical instructor at The Gorgas Course in Clinical Tropical Medicine and a F1000 Prime Associate Faculty Member in Tropical & Travel-Associated Diseases section. 

Positions and Honors

Honors and Scholarships

Memberships

Selected peer-reviewed publications 

1. Leon M, Alave J, Bustamante B, Gotuzzo E, Seas C. A probable assocaition between HTLV1 and endemic mycosis in Latin America. J Infect Dev Ctries. 2012;6(3):301. PMID: 22421616.

2. Leon M, Alave J, Alvarado R, Gotuzzo E, Terashima A, Seas C. A 52-year-old women with a subcapsular liver hematoma. Clin Infect Dis. 2011;52(9):1137. PMID: 21467019.

3. Alave J, Bustamante B, Soto L, Caceres J, Seas C. Acalculous Cholecystitis casused by Histoplasma capsulatum in a severely immunosuppressed HIV-infected patient. J Infect Dev Ctries. 2011;5(3):235-8. PMID: 21444995.

4. Leon M, Alave J, Martinez D, Bustamante B, Rodriguez M, Seas C. Symptotamic duodenal cryptoccosis in HIV-infected individuals. Med Mycol. 2011;49(7):775-8. PMID: 21355712.

5. Gonzales L, Alave JL, Paredes M, Molina C, Lopez G, Alvarez C, Tipismana M, Gotuzzo E. HTLV-1 associated myelopathy of rapid onset and progression following living-donor kidney transplant: Clinical description and initial response to empirical treatment. Retrovirology. 2011;8(Suppl 1):A56.

6. Leon M, Alave J, Chaparro E, Bustamante B, Seas C. A 13-yar-old with ataxia 4 weeks after a near-drowning accident. Clin Infect Dis. 2010;51(3):326-7,363-4. PMID: 20597680.

7. Leon M, Alave J, Bustamante B, Cok J, Gotuzzo E, Seas C. Human T lymphotropic virus 1 and paracoccidioidomycosis: a probable association in Latin America. Clin Infect Dis. 2010;51(2):250-1. PMID: 20560735.

Ongoing Research Support

1 UM1 AI 069438-07 (Sanchez) 12/01/2012 – 11/30/2013
NIH
The IMPACTA PERU Clinical Trials Unit
To evaluate HIV vaccine candidates, prophylaxis, and optimization of antiretroviral treatment, and to reduce HIV risky behaviors.
Role: Investigator

1 R01 DA032106-02 (Duerr) 07/15/12 – 04/30/13
US NIH/NIDA
HIV Testing and Treatment to Prevent Onward HIV Transmission among High-Risk MSM
The major goal of this study is to evaluate if early HIV diagnosis and treatment would prevent secondary HIV transmission among high risk MSM in Lima.
Role: Investigator

Biography

I am an HIV Research Scholar, with 10 year of experience as physician in the field of HIV/AIDS in Peru. From 2006 to 2010, I was resident of the specialty of infectious and tropical diseases. In 2011, I won a scholarship to start my master studies in epidemiological research at the Universidad Peruana Cayetano Heredia, Lima, Peru. Currently, I am a Junior Investigator at the IMPACTA PERU Clinical Trials Unit

Positions and Honors

Honors and Scholarships

Memberships

Selected peer-reviewed publications 

1. Leon M, Alave J, Bustamante B, Gotuzzo E, Seas C. A probable association between HTLV-1 and endemic mycosis in Latin America. J Infect Dev Ctries. 2012;6(3):301. PMID: 22421616.

2. Leon M, Alave J, Alvarado R, Gotuzzo E, Terashima A, Seas C. A 52-year-old women with a subcapsular liver hematoma. Clin Infect Dis. 2011;52(9):1195. PMID: 21467019.

3. Leon M, Alave J, Martinez D, Bustamante B, Rodriguez M, Seas C. Symptomatic duodenal cryptoccosis in HIV-infected individuals. Med Mycol. 2011;49(7):775-8. PMID: 21355712.

4. Leon M, Alave J, Chaparro E, Bustamante B, Seas C. A 13-yar-old with ataxia 4 weeks after a near-drowning accident. Clin Infect Dis. 2010;51(3):326-7,363-4. PMID: 20597680.

5. Leon M, Alave J, Bustamante B, Cok J, Gotuzzo E, Seas C. Human T lymphotropic virus 1 and paracoccidioidomycosis: a probable association in Latin America. Clin Infect Dis. 2010;51(2):250-1. PMID: 20560735.

6. Garcia C, Chincha O, Leon M, Iglesias D, Barletta F, Mercado E, et al. High frequency of diarrheagenic Escherichia coli in human immunodeficiency virus (HIV) patients with and without diarrhea in Lima, Peru. Am. J. Trop. Med. Hyg. 2010 Jun; 82(6):1118-1120. PMCID: PMC2877421.

7. Coralith García, Ariane Deplano, Olivier Denis, Mey León, Hugo Siu, Omayra Chincha et al. Spread of community-associated methicillin-resistant Staphylococcus aureus to Peru. J Infect. 2011 Dec; 63(6):482-3. PMID: 21920381.

Ongoing Research Support

1 UM1 AI 069438-07 (Sanchez) 12/01/2012 – 11/30/2013
NIH
The IMPACTA PERU Clinical Trials Unit
To evaluate HIV vaccine candidates, prophylaxis, and optimization of antiretroviral treatment, and to reduce HIV risky behaviors.
Role: IoR

1 UO1 AI068641 (Neaton) 06/29/2006 – 05/31/2013
NIH
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
TO3: Strategic Timing of Antirretroviral Therapy (START)
TO4: FLU002 and FLU003 studies.
Role: Physician

Biography

From April to July of 2012 I was Program Coordinator Prevention and control of sexually transmitted infections and HIV / AIDS at “Hospital Regional”, Ica, Perú and gained experience in developing strategies for early access to medical care and antiretroviral treatment.
Currently, I am junior investigator at the Asociacion Civil Impacta Salud y Educacion.

Positions and Honors

Honors and Scholarships

Memberships

Selected peer-reviewed publications 

1. Munayco C, Soto-Cabezas M, Valencia J, Huaroto F, Cucho C, Meza C, Hurtado J. Tuberculosis y migracion interna en un área endêmica Del sur Del Peru. Rev Peru Med Exp Salud Publica. 2009;26(3):324-17.

2. Rojas J, Garay M, Ortiz C, Flores H, Huaroto F, Chico H, Huamani I, Valencia J, Paz-Soldan C. Propuesta de un nuevo puntaje para optimizar estimados ecograficos de peso fetal: estudio piloto. Anales de la facultad de Medicina. 2009;70(2):109-14.

Ongoing Research Support

1 UM1 AI 069438-07 (Sanchez) 12/01/2012 – 11/30/2013
NIH
The IMPACTA PERU Clinical Trials Unit
To evaluate HIV vaccine candidates, prophylaxis, and optimization of antiretroviral treatment, and to reduce HIV risky behaviors.
Role: Investigator

1 R01 DA032106-02 (Duerr) 07/15/12 – 04/30/13
US NIH/NIDA
HIV Testing and Treatment to Prevent Onward HIV Transmission among High-Risk MSM
The major goal of this study is to evaluate if early HIV diagnosis and treatment would prevent secondary HIV transmission among high risk MSM in Lima.
Role: Investigator

Biography

I am an HIV Research Scholar, with 11 year of experience as physician in Peru, 6 of 11 year working in the field of HIV/AIDS. From 2004 to 2008, I was resident of the specialty of infectious and tropical diseases. From 2008 to 2009 I worked as attending physician at Asociacion Civil Selva Amazonica in Iquitos, Peru. In 2009, I won a scholarship to start my master studies in Publich Health Disease Control oriented at Institute of Tropical Medicine, Course in English, in Amberes, Belgium. Currently, I am a Junior Investigator at the IMPACTA PERU Clinical Trials Unit. 

Positions and Honors

Honors and Scholarships

Memberships

Selected peer-reviewed publications 

1. Montalbán E, Bustinza A, Vílchez G, Olarte L, Velarde J, Maguiña C. Erucismo por Lonomia spp con síndrome cutáneo hemorrágico. Primer caso reportado en Perú – 2006. Dermatol Peru 2008;18(4):354-358.

2. Pérez Gutiérrez ME, Izquierdo Caballero R, Montalbán E. Infective dermatitis associated with human T cell leukemia/lymphoma virus-1 infection. An Pediatrc (Barc). 2009;70(5):507-9. PMID: 19375987.

Ongoing Research Support

1 UM1 AI 069438-07 (Sanchez) 12/01/2012 – 11/30/2013
NIH
The IMPACTA PERU Clinical Trials Unit
To evaluate HIV vaccine candidates, prophylaxis, and optimization of antiretroviral treatment, and to reduce HIV risky behaviors.
Role: IoR

Positions and Honors

Experience and Professional Memberships

Selected peer-reviewed publications 

1. Montano SM, Villaran MV, Ylquimiche L, Figueroa JJ, Rodriguez S, Bautista CT, Gonzales AE, Tsung VCW, Gilman RH, Garcia HH for the Cysticercosis Working Group in Peru. Neurocysticercosis: associations between seizures, serology, and brain CT in rural Peru. Neurology 2005; 65(2): 229 – 33. PMID: 16043791.

2. Lescano AG, Garcia HH, Gilman RH, Gavidia CM, Tsang VC, Rodriguez S, Moulton LH, Villaran MV, Montano SM, Gonzalez AE; and the Cysticercosis Working Group in Peru. Taenia solium cysticercosis hotspots surrounding tapeworm carriers: clustering on human seroprevalence but not on seizures. PLoS Negl Trop Dis. 2009;3(1):e371. PMID: 19172178. PMCID: PMC2625436.

3. Villaran MV, Montano SM, Gonzalvez G, Moyano LM, Chero JC, Rodriguez S, Pan W, Gonzalez AE, Tang VCW, Gilman RH, Garcia HH for the Cysticercosis Working Group in Peru. Epilepsy and neurocysticercosis: an incidence study in a Peruvian rural population. Neuroepidemiology, 2009;33(1):25-31. PMID: 19325247. PMCID: PMC2826439.

4. Laguna-Torres VA, Gómez J, Ocaña V, Aguilar P, Saldarriaga T, Chavez E, Perez J, Zamalloa H, Forshey B, Paz I, Gomez E, Ore R, Chauca G, Ortiz E, Villaran M, Vilcarromero S, Rocha C, Chincha O, Jiménez G, Villanueva M, Pozo E, Aspajo J, Kochel T. Influenza-like illness sentinel surveillance in Peru. PLoS One. 2009;4(7):e6118. PMID: 19568433. PMCID: PMC2700970.

5. Kwon S, Lazo-Escalante M, Villaran MV, Li Cl. Relationship between interpregnancy interval and birth defects in Washington State. J Perinatol. 2012; 32(1): 45-50. PMID: 21546941.

6. Villaran MV, Montano SM, Bayer A, Konda KA, Mendoza C, Quijandria H, Apolaya M, Palacios O, Lescano AG, Vega AM, Blazes D, Kochel T. Condom use by Partner Type among Military and Police Personnel in Peru. Am J Mens Health. 2012; 6(4): 266-72. PMID: 22398988.

7. Castillo Ore RM, Forshey BM, Huaman A, Villaran MV, Long KC, Kochel TJ, Guevara C, Montgomery JM, Alvarez CA, Vilcarromero S, Morrison AC, Halsey ES. Serologic evidence for human hantavirus infection in Peru. Vector Borne Zoonotic Dis. 2012; 12 (8): 683-9. PMID: 22616720.

Ongoing Research Support

DHAPP 06/12 – 06/14
Programa de Mejoramiento de Laboratorios Militaries en America Latina (PROMELA)
This is a program that seeks to improve laboratory services of the armed forces of Central and South America for the diagnostic of HIV, TB, and STI patients, through the generation and capacity building of the staff responsible for the management of laboratories of the region. This program was born thanks to the initiative and effort of institutions as Department of Defense HIV/AIDS Prevention Program (DHAPP) and the U.S. Naval Medical Research Unit No.6 (NAMRU-6), with the collaboration of the Centers for Disease Control and Prevention and the United States President’s Emergency Plan for AIDS relief (PEPFAR).
Role: Program coordinator

RO1 NS-055627 (Zunt) 5/11 – 06/13
NIH/FIC/NINDS
Retroviral Infections of the Nervous System in Peru
The specific aims of this grant are to 1) define the risk determinants and clinical manifestations of HTLV-II, HTLV-I, HIV infections and of co-infections with two or more of these three retroviral pathogens in the four largest cities in Peru; 2) establish a national reference center for clinical research on HTLV infection for conduct of cohort studies of the natural history, clinical manifestations, and pathogenesis of HTLV-I and –II infections in persons referred from blood banks; and 3) examine the influence of these three retroviral infections on the natural history of opportunistic and tropical infections of the CNS in persons with retroviral infection.
Role: Local Co-PI

DHAPP/USAID 06/11 – 06/13
Prevalence and Prevention of HIV infection and selected STIs among Peruvian Armed Forces and National Police The Objectives of this study is to estimate the prevalence of HIV, syphilis and selected sexually transmitted infections in the active duty Peruvian military and assess risk factors related to HIV and selected STIs. As well as, to strengthen the capability for testing, training and prevention of HIV and related sexually transmitted infections in the Peruvian military, and p Provide a model for HIV testing and intervention that is applicable to other Latin American militaries in the region.
Role: PI

7 UM1 AI068614 - 07 (Corey) 06/01/12 - 05/31/13
NIH/NIAID
HIV Vaccine Trials Network
Role: Investigator

Biography

I am a Medical doctor with specialty on Infectious and Tropical Diseases, and the principal investigator of the Research Unit of the service of Infectious and Tropical Diseases at Hospital Nacional Dos de Mayo. Over the past 10 years, I have been an investigator in several NIH and non-NIH clinical trials.  I am the principal investigator of the satellite site Hospital Dos de Mayo for the ACTG A5225, a Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis. I fully support the present proposal IMPACTA Clinical Trials Unit and agree to serve as investigator for the San Miguel Clinical Research Site 11302.

Positions and Honors

Society Memberships

Honors

Selected Publications

1. Wiillingham FF, Ticona E, Taylor DN, Bowen AB, Crane AR, Gottlieb AL, Gayles MK, Grahn KF, Chavez Perez WM, Salas Apolinario I, Gilman RH. Diarrhea and Clostridium difficile infection in Latin American patients with AIDS. Working group on AIDS in Peru. Clin Infect Dis. 1998;27(3):487-93. PMID: 9770145.

2. Press N, Chávez VM, Ticona E, Calderon M, Apolinario IS, Culotta A, Arevalo J, Gilman RH; Working Group on AIDS in Peru. Screening for sexually transmitted diseases in human immunodeficiency Virus-positive Patients in Peru Reveals an absence of Chlamydia trachomatis and Identifies Tricomonas vaginalis in Pharyngeal Specimens. Clin Infect Dis. 2001; 32(5): 808-14. PMID: 11229850.

3. Mayta H, Gilman R, Arenas F, Valencia T, Caviedes L, Montenegro S, Ticona E, Ortiz J, Chumpitaz R, Evans C, Williams D: Tuberculosis Working Group in Peru. Evaluation of a PCR-Based Universal Heteroduplex Generator Assay as a tool for Rapid Detection of Multidrug-Resistant Mycobacterium tuberculosis in Peru. J Clin Microbiol. 2003;41(12):5774-7. PMID: 14662980. PMCID: PMC308991.

4. Campos P, Suárez P, Sánchez J, Zavala D, Arévalo J, Ticona E, Nolan C, Otón T, Holmes K. Multidrug Resistant Mycobacterium tuberculosis in HIV-Infected persons in Peru: Prevalence and Risk Factors. Emerg Infect Dis. 2003;9(12):1571-78. PMID: 14720398. PMCID: PMC3034326.

5. Baldwin M, Yori P, Moore D, Gilman R, Vidal C, Ticona E, Evans C. Tuberculosis and nutrition: disease perceptions and health seeking behavior of household contacts in the Peruvian amazon. Int J Tuberc Lung Dis. 2004; 8(12):1484-91. PMID: 15636496. PMCID: PMC2912521.

6. Moore D, Mendoza D, Gilman RH, Evans CA, Hollm Delgado MG, Guerra J, Caviedes L, Vargas D, Ticona E, Ortiz J, Soto G, Serpa J; Tuberculosis Working Group in Peru. Microscopic Observation Drug Susceptibility assay, a Rapid, Reliable Diagnostic Test for Multidrug-resistant tuberculosis suitable for use in Resource-Poor Settings. J Clin Microbiol. 2004;42(10):4432-7. PMID: 15472289. PMCID: PMC522377.

7. Kucerova Z, Moura H, Leitch G, Sriram R, Bern C, Kawai V, Vargas D, Gilman R, Ticona E, Vivar A, Visvesvara G. Purification of enterocytozoon bieneusi Spores from Stool Specimens by Gradient and Cell Sorting Techniques. J Clin Microbiol. 2004;42 (7):3256-61. PMID: 15243090. PMCID: PMC446316.

8. Vargas D, García L, Gilman R, Ticona E, Ñavincopa M, Luo R, Caviedes L, Hong C, Escombe R, Moore DA. Diagnosis of sputum-scarce HIV-associated pulmonary tuberculosis in Lima, Peru. Lancet. 2005; 365(9454):150-52. PMID: 15639297. PMCID: PMC2912523.

9. Kawai V, Soto G, Gilman RH, Bautista CT, Caviedes L, Huaroto L, Ticona E, Ortiz J, Tovar M, Chavez V, Rodriguez R, Escombe AR, Evans CA. Tuberculosis Mortality, Drug Resistance, and Infectiousness in patients with and without HIV infection in Peru. Am. J. Trop. Med. Hyg. 2006;75(6): 1027–1033. PMID: 17172361. PMCID: PMC2912515.

10. Escombe AR, Oeser C, Gilman RH, Navincopa M, Ticona E, Martinez C, Caviedes L, Sheen P, Gonzales A, Noakes C, Moore DA. The detection of airborne transmission of tuberculosis from HIV-infected patients, using an in vivo air sampling model. Clin Infect Dis. 2007;44(10):1349–57. PMID: 17443474. PMCID: PMC2912511.

11. Escombe AR, Moore DA, Gilman RH, Pan W, Navincopa M, Ticona E, Martínez C, Caviedes L, Sheen P, Gonzalez A, Noakes CJ, Friedland JS, Evans CA. The infectiousness of tuberculosis patients coinfected with HIV. PLoS Med. 2008;5(9):e188. PMID: 18798687. PMCID: PMC2535657.

12. Escombe AR, Moore DA, Gilman RH, Navincopa M, Ticona E, Mitchell B, Noakes C, Martínez C, Sheen P, Ramirez R, Quino W, Gonzalez A, Friedland JS, Evans CA. Upper-room ultraviolet light and negative air ionization to prevent tuberculosis transmission. PLoS Med. 2009;6(3):e43. PMID: 19296717. PMCID: PMC2656548.

13. Reddy KP, Brady MF, Gilman RH, Coronel J, Navincopa M, Ticona E, Chavez G, Sánchez E, Rojas C, Solari L, Valencia J, Pinedo Y, Benites C, Friedland JS, Moore DA. Microscopic observation drug susceptibility assay for tuberculosis screening before isoniazid preventive therapy in HIV-infected persons.Clin Infect Dis. 2010;50(7):988-96.

14. Escombe AR, Huaroto L, Ticona E, Burgos M, Sanchez I, Carrasco L, Farfán E, Flores F, Moore DA. Tuberculosis transmission risk and infection control in a hospital emergency department in Lima, Peru. Int J Tuberc Lung Dis. 2010 Sep;14(9):1120-6. PMID: 20192727. PMCID: PMC2947458.

15. Soria J, Bull M, Mitchell C, Rosa AL, Dross S, Kraft K, Coombs R, Ticona E, Frenkel L. Transmitted HIV Resistance to First-Line Antiretroviral Therapy in Lima, Peru. AIDS Res Hum Retroviruses. 2012;28(4):333-8. PMID: 21819256. PMCID: PMC3316114.

Completed Research Support 

TMC207-TiDP13-C208 01/14/09 – 08/15/12
Tibotec BVBA
A Phase II, placebo-controlled, double blind, randomized trial to evaluate the antibacterial activity, safety, and tolerability of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB).
The main goal of this study is to evaluate the pharmacokinetics, anti-bacterial activity, safety, and tolerability of TMC207 compared to placebo when added for 8 weeks to a BR, in subjects with newly diagnosed sputum smear-positive pulmonary MDR-TB infection.
Role: PI

R01 AI071212-01A2 06/27/07 – 08/12
NIH
Mechanism/predictors of genital/rectal HIV shedding during ART w/plasma <50c/mL
The main goal of this study is to determine amount of patients with < 50c/mL of HIV in plasma that have detectable HIV in genital secretions, as well as the factors associate.
Role: PI

Biography

I am currently the Chief of the Health Intelligence Office (what includes epidemiology) at the Red Asistencial Rebagliati and Hospital Edgardo Rebagliati Martins of the Peruvian Social Secutiry System. I have been Director of the Office for Clinical Research and Technology Transfer at the Peruvian NIH, institution that is in charge of approving and monitoring the implementation of clinical trials in Peru; Chief of the department of Ob&Gyn of Hospital Dos de Mayo; Executive Director of Epidemiology at the V Health Direction of Lima, Peru.

I am currently faculty at the graduate program of the school of medicine of the Universidad San Martin de Porres.  I have mentored 29 scholars from the Multidisciplinary International Research Training Program over the past 15 years. I have served as investigator in the Latin American AIDS Research and Training Program (LAARTP). I will continue serving the IMPACTA Peru Clinical Trials Unit in the area of women and HIV. I am the investigator of Record for the study ACTG5282 funded by the AIDS Clinical Trials Group (ACTG) and protocol team member for ACTG 5216 also funded by ACTG. I will continue collaborating as Investigator for the San Miguel Clinical Research Site of the IMPACTA Peru Clinical Trials Unit in the area of women and HIV.

Positions and Honors

Experiences and Professional Memberships

Selected Publications

1. Sanchez SE, Koutsky LA, Sanchez J, Fernandez A, Casquero J, Kreiss J, Catlin M, Xia M, Holmes KK. Rapid and inexpensive approaches to managing abnormal vaginal discharge or lower abdominal pain: an evaluation in women attending gynaecology and family planning clinics in Peru. Sex Transm Infect. 1998;74 Suppl 1:S85-94. PMID: 10023357.

2. Sanchez SE, Williams MA, Muy-Rivera M, Qiu C, Vadachkoria S, Bazul V. A case-control study of oxidized low density lipoproteins and preeclampsia risk. Gynecol Endocrinol. 2005;21(4):193-9. PMID: 16316839.

3. Sanchez SE, Pacora PN, Farfan JH, Fernandez A, Qiu C, Ananth CV, Williams MA. Risk factors of abruptio placentae among Peruvian women. Am J Obstet Gynecol. 2006;194(1):225-30. PMID: 16389036.

4. Qiu C, Sanchez SE, Larrabure G, David R, Bralley JA, Williams MA. Erythrocyte omega-3 and omega-6 polyunsaturated fatty acids and preeclampsia risk in Peruvian women. Arch Gynecol Obstet. 2006;274(2):97-103. PMID: 165220922.

5. Sanchez SE, Qiu C, Perales MT, Lam N, Garcia P, Williams MA. Intimate partner violence (IPV) and preeclampsia among Peruvian women. Eur J Obstet Gynecol Reprod Biol. 2008;137(1):50-5. PMID: 17600610.

6. Cripe SM, Sanchez SE, Perales MT, Lam N, Garcia P, Williams MA. Association of intimate partner physical and sexual violence with unintended pregnancy among pregnant women in Peru. Int J Gynaecol Obstet. 2008;100(2):104-8. PMID: 17963763.

7. Gomez-Beloz A, Williams MA, Sanchez SE, Lam N. Intimate partner violence and risk for depression among postpartum women in Lima, Peru.. Violence Vict. 2009;24(3):380-98. PMID: 19634363.

8. Cripe SM, Sanchez S, Lam N, Sanchez E, Ojeda N, Tacuri S, Segura C, Williams MA. Depressive symptoms and migraine comorbidity among pregnant Peruvian women.J Affect Disord. 2010;122(1-2):149-53. PMID: 19695709. PMCID: PMC2835839.
9. Gelaye B, Lam N, Cripe SM, Sanchez SE, Williams MA. Correlates of violent response among Peruvian women abused by an intimate partner. J Interpers Violence. 2010;25(1):136-51. PMID: 19252073.

10. de Paz NC, Sanchez SE, Huaman LE, Chang GD, Pacora PN, Garcia PJ, Ananth CV, Qiu C, Williams MA. Risk of placental abruption in relation to maternal depressive, anxiety and stress symptoms. J Affect Disord. 2011;130(1-2):28-4. PMID: 20692040. PMCID: PMC2994998.

11. Cripe SM, Sanchez SE, Sanchez E, Ayala Quintanilla B, Alarcon CH, Gelaye B, Williams MA. Intimate Partner Violence During Pregnancy: A Pilot Intervention Program in Lima, Peru. J Interpers Violence. 2010;25(11)2054-76. PMID: 20145196. PMID: 20145196.

12. Knowles KM, Paiva LL, Sanchez SE, Revilla L, Lopez T, Yasuda MB, Yanez ND, Gelaye B, Williams MA. Waist circumference, body mass index, and other measures of adiposity in predicting cardiovascular disease risk factors among Peruvian adults. Int J Hypertens. 2011;2011:931402. PMID: 21331161. PMCID: PMC3034939.

13. de Paz NC, Sanchez SE, Huaman LE, Chang GD, Pacora PN, Garcia PJ, Ananth CV, Qiu C, Williams MA. Risk of placental abruption in relation to maternal depressive, anxiety and stress symptoms. J Affect Disord. 2011;130(1-2):280-4. PMID: 20692040. PMCID: PMC2994998.

14. Sanchez SE, Alva AV, Diez Chang G, Qiu C, Yanez D, Gelaye B, Williams MA. Risk of Spontaneous Preterm Birth in Relation to Maternal Exposure to Intimate Partner Violence During Pregnancy in Peru. Matern Child Health J. 2012 April 17. PMID: 22527763.

15. Perla ME, Ghee AE, Sánchez SE, McClelland RS, Fitzpatrick AL, Suárez-Ognio L, Lama JR, and Sánchez J. Genital Tract Infections, Bacterial Vaginosis, HIV, and Reproductive Health Issues among Lima-Based Clandestine Female SexWorkers. Infect Dis Obstet Gynecol. 2012;2012:739624. PMID: 22811592. PMCID: PMC3395213.

Ongoing Research Support

5R01HD059827-02 (Michelle Williams) 17/08/12 – 04/30/13
NIH
Triggers of Abruptio Placentae – A Case Crossover Study of an Ischemic Placental Disorder
This is a multi-center epidemiologic study of Abruptio placentae (AP) in Lima, Peru. We will use the self-matched case-crossover design to evaluate the acute effects of: 1) maternal smoking and alcohol consumption; 2) physical exertion; 3) sexual activity; 4) abdominal trauma secondary to falls or motor vehicle crashes; and 5) exposure to intimate partner violence as potential "triggers" of AP. The risk of AP will be assessed during pre-specified hazard periods. We will also use the case-control replicative (two stage) study design to study genetic variants that influence the pathogenesis of AP in well characterized 900 mother-infant abruption case pairs and 900 mother-infant control pairs. We plan to focus on specific gene pathways, including coagulation, fibrinolysis, platelet function, infection and inflammation, angiogenesis, folate metabolism, and the renin-angiotensin systems that have previously been associated with AP.
Role: Co-Principal Investigator

1 R01 HD059835-01ª2, (Michelle Williams) 05/17/11 – 04/17/16
NIH
A cohort study of Preterm Delivery in Relation to Partner Abuse, Mood and Anxiety Disorders: An observational study of 6,000 Peruvian women to determine whether the risk of preterm delivery is influenced by maternal mental health status and/or exposure to violence before and during pregnancy
Role: Co-Principal Investigator

Biography

Surgeon specializing in internal medicine and infectious diseases, a doctor of Infectious Diseases Unit of the Hospital Guillermo Almenara (HNGAI) since 2000 and also in infectious diseases of the HIV clinic Vía Libre Association since 2000.

Dr. Hidalgo is principal investigator INSIGHT network since 2010 and HNGAI Vía Libre, as well as investigator and co-investigator of multiple biomedical studies and clinical trials of anti-retroviral therapy and infectious diseases.

Positions and Honors

List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee.

Selected peer-reviewed publications 

1.Hidalgo JA, Castillo N, Agurto C. Newly diagnosed HIV patients in Lima, Peru: a comparison of individuals diagnosed through an intervention program versus self-referred individuals. Journal of the International AIDS Society 2010, 13(Suppl 4):P171.

2.Castillo, N, Agurto C, Benites C, Hidalgo JA. Five-year outcomes of HAART at a non-governmental treatment center in Lima, Peru. Journal of the International AIDS Society 2010, 13(Suppl 4):P173.

3.Collins JA, Hernandez AV, Hidalgo JA, Salazar R; HTLV-1 infection is not associated with a high risk of death in Peruvian HIV-infected patients. Rev Inst Med Trop S Paulo 2009; 51(4):197-201.

4.Silverberg MJ, Neuhaus J, Bower M, Gey D, Hatzakis A, Henry K, Hidalgo J, Lourtau L, Neaton JD, Tambussi G, Abrams DI; Risk of cancers during interrupted antiretroviral therapy: malignant outcomes in the SMART study. AIDS 2007; 21(14): 1957-63.

5.Mora CS, Sagemi MI, Hidalgo JA; Strongyloides stercoralis hyperinfection in systemic lupus erythematosus and the antiphospholipid syndrome. Semin Artritis Rheum 2006; 36(3):135-43

6.Collins JA, Hernandez AV, Hidalgo JA, Villena J, Sumire J, Delgado V, Salazar R; High proportion of T cell systemic non-Hodgkin lymphoma in HIV infected patients in Lima, Peru. J Acquir Immune Defic Syndr JAIDS 40(5):558-64 2005.

7.Weigelt J, Itani K, Stevens D, Lau W, Dryden W, Knirsch C, and the Linezolid CSSTI Study Group, Linezolid versus Vancomycin in Treatment of Complicated Skin and Soft Tissue Infections; Antimicrobial Agents Chemotherapy, 2005, 49(6):2260–2266 (as member of the Linezolid Study Group).

Research Support

• Principal Investigator, Strategic Timing of Antiretroviral Therapy (START), INSIGHT Network, 2011, Via Libre, Lima, Peru.

• Principal Investigator, ENCORE Clinical Trial (reduced dose of efavirenz as initial treatment for HIV), 2010, Via Libre, University of New South Wales, Australia.

• Co-Investigator, Strategic Timing of Antiretroviral Therapy (START), INSIGHT Network, 2010, Guillermo Almenara Hospital, Lima, Peru.

• Principal Investigator Ceftobiprole clinical trial BAP00248 (nosocomial pneumonia), 2006-07.

• Co-investigator, Strategies on Management of Antiretroviral Therapy (SMART Study), CPCRA 065, 2004-07.

• Sub-investigator, Raltegravir clinical trial MK-021 (Oct 2006, ongoing).

• Sub-Investigator, Atazanavir Clinical Trials BMS-034 & BMS-043, Bristol, Myers & Squibb, April 01- June 03; BMS-138 (June 2006, ongoing).

• Sub-investigator, Micafungin clinical trials for esophageal candidiasis 03-7-005 (Oct 03-Feb 04) and 03-7-008 (May 04-Feb 05), Fujizawa/PPD.

Biography

Surgeon, specializing in Infectious and Tropical Diseases. Dr. Mendo is infectious National Hospital Edgardo Rebagliatti Martins (HNERM), Chief of Program Infectologia and sexually transmitted infections and HIV Essalud since 2005 and professor in the faculty of medicine at the Universidad Peruana de Ciencias (UPC ).

Dr. Mendo has been head of the national cholera IPSS, committee member of nosocomial infections and Clinical Pharmacology Unit HNERM and graduate tutor infectious diseases at the National University of San Marcos.

Positions and Honors

Selected peer-reviewed publications 

1.Manual de Terapéutica Medica para el primer nivel de atención. Editor: Alejandro Midzuaray. Servicios de Medicinas Pro-Vida. 1998.

2.Impact of HAART for hospitalizations rates in Latin American Hospital. 9th International Congress on Infectious
Diseases. Buenos Aires. 2000

3.Side effects for HAART at Hospital Edgardo Rebagliati Martins. 9th International Congress on Infectious 
Diseases. Buenos Aires. 2000

Research Support

Biography

Specialist in Internal Medicine and Infectious and Tropical Diseases. Dr. Salazar is a researcher, former Chief of Internal Medicine and Infectious Diseases Unit at the Hospital Guillermo Almenara EsSalud. Likewise, Dr. Salazar is a senior lecturer in internal medicine at the Universidad Nacional Mayor de San Marcos (San Marcos), representative of Peru in the AIDS Committee of the Pan American Association for Infectious Diseases, also member of the advisory board of the Foundation and Hipólito Unanue Associate Member of the National Academy of Medicine.

Positions and Honors

Selected peer-reviewed publications 

1.Salazar R, Valenzuela, G. "CARDIAC AFFECTATION IN AIDS – THE FIRST PERUVIAN MULTICENTRIC STUDY". X International Congress on Infectious Diseases. Singapur – July 2002.

2.Salazar R, Valenzuela, G. "HEART COMPROMISE IN AIDS – RESULTS FROM THE FIRST PERUVIAN MULTICENTRIC COHORT". XIV International Aids Conference. Barcelona – España. July 2002.

3.Salazar R, Villena, J. "ONCE DAILY SAQUINAVIR-SGC/RITONAVIR MINIDOSIS + 2NRTIs IS AS EFFECTIVE IS SAQUINAVIR-SGC (CONVENTIONAL DOSE) + 2NRTIs IN ANTIRETROVIRAL – NAIVE PATIENTS WITH ADVANCED HIV INFECTION: RESULTS AT 24 WEEKS". XIV International Aids Conference. Barcelona – España. July 2002.

4.Salazar R, Hidalgo J, "ESTUDIO PILOTO DE LA COMBINACION RITONAVIR 100mg /SAQUINAVIR 1600 mg (UNA TOMA DIARIA EN EL TRATAMIENTO DE PACIENTES VIH-POSITIVOS CON INFECCION AVANZADA, REPORTE A 52 SEMANAS". XI Congreso Panaméricano de Infectología. Cordoba – Argentina. May 2003.

5.Salazar R, Claros J, "HIPERLIPIDEMIA EN PACIENTES CON VIH Y 2 AÑOS DE TARV CON INDINAVIR O NELFINAVIR EN LIMA-PERU". XI Congreso Panaméricano de Infectología. Cordoba – Argentina. May 2003.

6.Salazar R, Chumpitaz, "TERAPIA ANTIRETROVIRAL TRIPLE CON DOSIS BAJAS DE ZIDOVUDINA (AZT): EVALUACION A LAS 52 SEMANAS DE TRATAMIENTO". XI Congreso Panaméricano de Infectología. Cordoba – Argentina. May 2003.

7.Salazar R, Collins J, "PREDICTORES DE SOBREVIDA DEL LINFOMA NO HODGKIN SISTEMICO ASOCIADO A VIH EN LIMA-PERU". XI Congreso Panaméricano de Infectología. Cordoba – Argentina. May 2003.

8.Salazar R, Collins J, "HIGH PROPORTION OF T-CELL SYSTEMIC NON-HODGKINS LYMPHOMA (SNHL) IN HIV INFECTED INDIVIDUALS IN LIMA-PERU". The 2nd IAS Conference on HIV Pathogenesis and Treatment . Paris – France 13-16 July, 2003.

9.Salazar R. et al "A small group of peruvian HIV patients with Primary Cerebral Lymphoma (PCL)". XV INTERNATIONAL AIDS CONFERENCE, Bangkok - Tailandia,11 -16,July 2004.

10.Salazar R, et al "Effect of HTLV-1 infection on survival of a cohort of peruvian Hiv – Infected Patients". XV INTERNATIONAL AIDS CONFERENCE, Bangkok - Tailandia, 11 – 16, July 2004.

11.Salazar R, et al "Effect of Antiretroviral Therapy on survival of HIV – infected Tuberculosis patients in Lima, Peru". XV INTERNATIONAL AIDS CONFERENCE, Bangkok - Tailandia, 11 – 16, July 2004.

12.Salazar,R., et al. : “Causes of hospitalization and deathin HIV-positive patients receiving antiretroviral therapy in Lima, Peru”. XV INTERNATIONAL AIDS CONFERENCE. Bangkok, Tailandia, 11-16, July 2004.

13.Salazar R, et al "Clinical characteristics of tuberculosis diagnosed in HIV – positive persons receiving HAART". 3rd IAS CONFERENCE, Rio de Janeiro - Brasil,24-27, July 2005.

14.Salazar, R., et al.: “Prevalence of HTLV-1 infection in a large cohort of patients with sexually transmitted HIV infection in Lima, Peru” 3rd IAS CONFERENCE, Rio de Janeiro, Brasil, 24- 27 July 2005.

15.Corey,D., Woo Kim,H., Salazar,R., Gutierrez,L.,Sanchez,J.,Tabet,S. “ The Natural History of Untreated HIV Infection in Lima, Peru”. Human Vaccines. Vol. 1 Issue 4, July/August, 2005.

16.SMART Study Group. “CD4+ Count-Guided Interruption of Antiretroviral Treatment”. N Engl J Med. Vol 355 N° 22, November 30, 2006.

17.Corey,D., Woo Kim, H., Salazar, R., Illescas,R., Villena,J., Gutierrez,L.,Sanchez,J.,Tabet,S. “Effectiveness of Combination Antiretroviral Therapy on Survival and Opportunistic Infections in a Developing World Setting”. J Acquir Immune Defic Syndrome.Vol 44,number 4, April,2007.

Books and Chapters

• Salazar R. ANTIBIOTICOS EN LA PRACTICA MEDICA. EN: MEDICAMENTOS ESENCIALES EN LA PRACTICA MEDICA GENERAL. LIMA: COLEGIO MEDICO DEL PERU, 1984.

• Salazar R. ANTIBIOTICOS β-PENICILINA. EN: ANTIBIOTICOS Y QUIMIOTERAPICOS. LIMA: COLEGIO MEDICO DEL PERU, 1985.

• Salazar R. Celis E, Villena J, Fajardo O, Gutierrez L, Lopez E, Illescas R. EL COLERA EXPERIENCIA EN EL IPSS. LIMA: MEDILIBROS - IPSS, 1992.

• Salazar R. NEUMONIA INTRAHOSPITALARIA. EN: MARTINEZ J, LEON BARUA R, VIDAL L, LOSNO R. Eds. EMERGENCIAS EN MEDICINA INTERNA.. LIMA - PERU, 1996.

Completed Research Support 

905-MK 0639 SALAZAR (PI) 2000-2002
MSD
A MULTICENTER, OPEN-LABEL, RANDOMIZED, FORTY-EIGHT-WEEK, STUDY TO COMPARE THE SAFETY TOLERABILITY, AND EFFICACY OF INDINAVIR SULFATE 800mg bid, RITONAVIR 100mg bid, AND TWO NEW NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS vs NELFINAVIR 1250 mg bid AND TWO NEW NRTIs IN PROTEASE INHIBITOR NAIVE PATIENTS.
The major goals of the project are to investigate the differences in proportion of patients with plasma viral rna<400 COPIAS/Ml; and to compare the durability of antiviral treatment.

AI424-034 SALAZAR (PI) 2001-2002
BMS
A PHASE III STUDY COMPARING THE ANTIVIRAL EFFICACY AND SAFETY OF BMS - 232632 WITH EFAVIRENZ; EACH IN COMBINATION WITH FIXED DOSE ZIDOVUDINE - LAMIVUDINE.

The major goal of the project is to compare the antiviral activity of the two treatment arms at week 48, defined as comparison of the proportion of subjects responding to treatment witch hiv rna levels< 400 c/ ml for the bms 232632/efv placebo/zav-3tc arm VS the efv/bms 23263 placebo/zav- 3tc arm.

M99-046 SALAZAR (PI) 2001-2002
ABBOTT
ABT-378/r (ABT-378/ritonavir) EARLY ACCESS PROGRAM

The objectives of this study are to make abt-378/R available to hiv-infected subjects who have failed and/or are intolerant to combination therapy with available antiretroviral agents and have limite remaining treatment options available to them and to obtain additional safety information on abt-378/R.

AI424-045 SALAZAR (PI) 2002-2003
BMS
A RANDOMIZED OPEN – LABEL STUDY OF THE ANTIVIRAL EFFICACY AND SAFETY OF ATAZANAVIR, IN COMBINATION WITH RITONAVIR OR SAQUINAVIR, AND THE COMBINATION OF LOPINAVIR/RITONAVIR EACH WITH TENOFOVIR AND A NUCLEOSIDE IN SUBJECTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE.
The major goal is to compare the Atazanavir treatment regimens to the Lopinavir/RTV regimen in the magnitude of reduction or plasma HIV RNA from baseline, expressed in logarithm, (as assessed by the TAD) through 24 weeks (and week 48).

AI424-043 SALAZAR (PI) 2002-2003
BMS
A RANDOMIZED OPEN – LABEL STUDY OF THE ANTIVIRAL EFFICACY AND SAFETY OF ATAZANAVIR VERSUS LOPINAVIR/RITONAVIR (LPV/RTV), EACH IN COMBINATION WITH TWO NUCLEOSIDES IN SUBJECTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE WITH PRIOR PROTEASE INHIBITOR – CONTAINING HAART REGIMEN (S)

The major goal is to compare the two treatment regimens with regard to serum lipid profile, as assessed by the change in LDL cholesterol levels from baseline at week 24. To compare the two treatment regimens in the magnitude of the reduction of plasma HIV RNA from baseline, expressed in log 10, (as assessed by the TAD) through 24 weeks.

P00738 SALAZAR (PI) 2002 – 2003
Schering Plough Research Institute
PHASE III STUDY OF PEG-INTRON IN HEAVILY TREATMENT – EXPERIENCED, HIV INFECTED PATIENTS

The objective of this study is to evaluate the safety and efficacy of PEG-INTRON when added to stable optimized background antiretroviral therapy in a population of heavily treatment – experienced HIV-1 infected subjects.

SMART(065-003) SALAZAR (PI) 2005 – 2007
A LARGE, SIMPLE COMPARING TWO STRATEGIES FOR MANAGEMENT OF ANTIRETROVIRAL THERAPY

To compare the long-term clinical consequences of two strategies of antiretroviral management: the DC Strategy (drug conservation), a strategy aimed at conserving drugs through episodic use of antiretroviral treatment for the minimum time to maintain CD4+ cell count = 250 cells/mm3 versus the VS Strategy (viral suppression), a strategy aimed at suppressing viral load as much as possible immediately following randomization and throughout follow-up, irrespective of CD4+ cell count.

Biography

Clinical Psychologist with extensive experience as chief coordinator and work area in men who have sex with men (MSM) and People Living with HIV (PLHIV). Experience in planning, organizing and executing large events and community activities. Experience in leadership training and peer educators promoters. Experience managing community centers in Lima.

Courses and Training

Work Experience

Publications

Co Autor de articulo “HPV and Genital Warts among Peruvian Men Who Have Sex with Men and Transgender People: Knowledge, Attitudes and Treatment Experiences”
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0058684;jsessionid=5FA410F7881A18991D78EC1E2F603775
PLOS one, Febrero 2013

Co Autor de artículo “From personal survival to public health: community leadership by men who have sex with men in the response to HIV”
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60834-4/fulltext
LANCET, Julio 2012

Autor de libro de cuentos de temática gay lésbica: “Siete formas de Decir Adiós”
https://www.facebook.com/photo.php?v=3812155136931&set=vb.1069108749&type=3&theater
Julio 2012

Biography

I hold a master in social work from the University of Washington, and I am currently a PhD candidate in Infection and Population Health from the University College, London. My primary area of interest is the acceptability of emerging biomedical HIV prevention interventions (e.g., vaccines, pre-exposure prophylaxis, microbicides), diagnostics (e.g. in-home use of rapid HIV testing), and combining both qualitative and relatively novel quantitative methodologies such as discreet choice analysis to model hypothetical multi-attribute interventions and their potential update among targeted users. I have collaborated with the Asociacion Civil Impacta Salud y Educacion on a range of studies since 2001 including HPTN 036 and HPTN 039 funded by the HIV Prevention Trials Network.

I fully support the IMPACTA Peru Clinical Trials Unit proposal and will bring my expertise in HIV/AIDS research particularly in the area of qualitative research methods and the acceptability of emerging biomedical HIV prevention interventions such as Pre-exposure Prophylaxis and Rectal Microbicides.

Positions and Honors

Honors

Selected Publications

1. Clark JL, Salvatierra HJ, Salazar X, Segura ER, Konda KA, Galea JT, Klausner JD, Coates TJ, Caceres CF. Frequency, Patterns and Preferences of Lubricant Use During Anal Intercourse Within Male Sexual Partnerships in Lima, Peru: Implications for a Rectal Microbicide HIV Prevention Intervention. AIDS Care. 2012. [Epub ahead of print]. PMID: 23082796.

2. Kinsler JJ, Galea JT, Lama JR, Segura P, Peinado J, Casapia M, Ortiz A, Nadjat-Haiem C, Montano SM, Sanchez J. Rectal douching among Peruvian men who have sex with men, and acceptability of a douche-formulated rectal microbicide to prevent HIV infection. Sex Transm Infect. 2012. [Epub ahead of print]. PMID: 22773324.

3. Kinsler JJ, Cunningham WE, Nureña CR, Nadjat-Haiem C, Sánchez J, Casapía M, Montoya-Herrera O, Grinsztejn B, Galea JT. Using Conjoint Analysis to Measure the Acceptability of Rectal Microbicides among Men Who Have Sex with Men in four South American Cities. AIDS Behav. 2012;16(6):1436-47. PMID: 21959986.

4. Young SD., Konda K, Caceres C, Galea J, Sung-Jae L, Salazar X, Coates T. Effect of a Community Popular Opinion Leader HIV/STI Intervention on Stigma in Urban, Coastal Peru. AIDS Behav. 2011;15(5):930-7. PMID: 20953691. PMCID: PMC3110996.

5. Kinsler J, Galea JT, Peinado J, Segura P, Montano S., Sánchez J. Lubricant use among MSM reporting receptive anal intercourse in Peru: Implications for Rectal Microbicides as an HIV prevention strategy. Int J STD AIDS 2010; 21(8): 567–72. PMID: 20975090.

6. Galea JT, Kinsler J, Salazar X, Lee SJ, Girón M, Sayles J, Cáceres C, Cunningham C. Acceptability of Pre-Exposure Prophylaxis (PrEP) as an HIV prevention strategy: Barriers and facilitators to PrEP uptake among at-risk Peruvian populations. Int J STD AIDS. 2011;22(5):256-62. PMID: 21571973. PMCID: PMC3096991.

7. Cáceres CF, Aggleton P, Galea, JT. Sexual Diversity, Social Inclusion and HIV/AIDS. AIDS. 2008; 22 Suppl 2:S45-55. PMID: 18641469. PMCID: PMC3329729.

8. Villacorta V, Kegeles S, Galea J, Konda KA, Cuba JP, Palacios CF, Coates TJ; NIMH Collaborative HIV/STD Prevention Trial Group. Innovative Approaches to Cohort Retention in a Community-Based HIV/STD Prevention Trial for Socially Marginalized Peruvian Young Adults. Clin Trials. 2007; 4(1): 32-41. PMID: 17327244. PMCID: PMC2853960.

9. Gorbach PM, Galea JT, Amani B, Shin A, Celum C, Kerndt P, Golden MR: Don’t ask, don’t tell: patterns of HIV disclosure among HIV positive men who have sex with men practicing high risk behavior in Los Angeles and Seattle: Sex Transm Infect. 2004, 80(6): 512-7. PMID: 15572626. PMCID: PMC1744943.

10. Gorbach PM, Aral SO, Celum C, Stoner BP, Whittington WL, Galea J, Coronado N, Connor S, Holmes, KK. To Notify or Not to Notify: STD Patients’ Perspectives of Partner Notification in Seattle. Sex Trans Dis. 2000; 27(4), 193-200. PMID: 10782740.

Ongoing Research Support

IISP #39619 (Brown) 11/1/2011-1/1/2014
Merck
The role of genital warts in HIV acquisition among MSM in Lima, Peru
The primary objective of this study is to determine the role of GW on HIV acquisition among MSM in Peru. The secondary objectives are to determine HPV prevalence in HIV positive MSM in Peru, and the knowledge of HPV and HIV among MSM.
Role: Co-Investigator

1DP2OD00663 (Cohen) 1/1/10-8/31/14
NIH/NIGMS
Prevalence, Risk Factors and Consequences of Complex M. Tuberculosis Infections
This study evaluates the prevalence, risk factors and consequences of complex M. tuberculosis infection. The aims are to 1) estimate the site-specific prevalence of multiple strain M. tuberculosis infection and clonal heterogeneity among individuals at the time of initial diagnosis; 2) determine the host- and strain- related risk factors for multiple strain infection and clonal heterogeneity; 3) evaluate the effect of multiple-strain infection and clonal heterogeneity on early response to standard first-line treatment regimens; and 4) develop mathematical models to examine the individual- and population-level effects on multiple-strain infection and clonal heterogeneity.
Role: Project Director

Biography

During the past 10 years, after graduating in Internal Medicine, Infectious Diseases and HIV-AIDS specialty training in the U.S., I conducted clinical research in Peru, with projects focusing on the treatment of HIV-AIDS. Most of this research has been in the AIDS Clinical Trials Group (ACTG) and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), both funded by the NIAID Division of AIDS.

My present duties along those lines are local Principal Investigator of several clinical trials, and also co-president of two international multicenter ACTG studies of second-line antiretroviral therapy in resource-limited settings, ie A5234 and A5273.

We have established a partnership with the Seattle group, with Dr. Ann Collier as our mentor in the past six years, and has also a close collaboration with Dr. Lisa Frenkel and Ticona doctor at the Hospital Dos de Mayo, which results in a study of discordant shedding among Peruvian adults. I agree to serve as the site leader IMPACTA Barranco Peru CRS Clinical Trials Unit.

Positions and Honors

Experiencia y Asociaciones Profesionales

Selected peer-reviewed publications 

1. Llanos-Cuentas A, Echevarria J, Cruz M, La Rosa A, Campos P, Campos M, Franke E, Berman J, Modabber F, Marr J. Efficacy of sodium stibogluconate alone and in combination with allopurinol for treatment of mucocutaneous leishmaniasis. Clin Infect Dis. 1997;25(3):677-84. PMID: 9314461.

2. La Rosa A, Weigand M, Rolston KV. Actinomycosis: an unusual infection presenting as or complicating malignancy. Infectious Diseases in Clinical Practice 2000; 9(8): 331-3.

3. La Rosa AM, Champlin RE, Mirza N, Gajewski J, Giralt S, Rolston KV, Raad I, Jacobson K, Kontoyiannis D, Elting L, Whimbey E. Adenovirus infections in adult recipients of blood and marrow transplants. Clin Infect Dis. 2001; 32 (6): 871-6. PMID: 11247710.

4. La Rosa A, Whimbey E. Section of Clinical Microbiology, Chapter: Respiratory Viruses. In textbook: Infectious Diseases. Second Edition. Lead Editors: Jonathan Cohen, William G. Powderly. Mosby 2002.

5. Zunt J, La Rosa A, Peinado J, Lama J, Suarez L, Pun M, Cabezas C, Sanchez J. Risk factors for HTLV-II infection in Peruvian men who have sex with men. Am J Trop Med Hyg. 2006 May;74(5):922-5. PMID: 16687704. PMCID: PMC2695970.

6. The Strategies for Management of Antiretroviral Therapy (SMART) Study Group, et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006; 355(22):2283-96. PMID: 17135583.

7. La Rosa AM, Zunt JR, Peinado J, Lama JR, Ton TG, Suarez L, Pun M, Cabezas C, Sanchez J; et.al. Retroviral Infection in Peruvian Men Who Have Sex with Men. Clin Infect Dis. 2009; 49(1):112-7. PMID: 19480577. PMCID: PMC2770590.

8. Belloso W, Orellana L, Grinsztejn B, La Rosa A, et.al. Analysis of serious Non-AIDS events among HIV-infected adults in Latin American Sites. HIV Med. 2010;11(9):544-64. PMID: 20345879

9. Neuhaus J, Angus B, Kowalskac J, La Rosa A, et.al. Risk of all-cause mortality associated with nonfatal AIDS and serious non-AIDS events among adults infected with HIV. AIDS. 2010; 24(5):697–706. PMID: 20177360. PMCID: 2897168.

10. Neuhaus J, Jacobs DR, Baker JV, Calmy A, Duprez D, La Rosa A, et.al. Markers of Inflammation, Coagulation, and Renal Function Are Elevated in Adults with HIV Infection. J Infect Dis. 2010; 201(12):1788-95. PMID: 20446848. PMCID: PMC2872049.

11. Firnhaber C, Smeaton L, Saukila N, Flanigan T, Gangakhedkar R, Kumwenda J, La Rosa A, et.al. Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas. Int J Infect Dis. 2010; 14(12):e1088-92. PMID: 20961784. PMCID: PMC3021118.

12. Robertson K, Kumwenda J, Supparatpinyo K, Jiang JH, Evans S, Campbell TB, Price RW, Murphy R, Hall C, Marra CM, Marcus C, Berzins B, Masih R, Santos B, Silvia MT, Kumarasamy N, Walawander A, Nair A, Tripathy S, Kanyama C, Hosseinipour M, Montano S, La Rosa A, et.al. A multinational study of neurological performance in antiretroviral therapy-naïve HIV-1-infected persons in diverse resource-constrained settings. J. Neurovirol. 2011;17:438–447. PMID: 21786076. PMCID: PMC3362044.

13. Robertson K, Jiang H, Kumwenda J, Supparatpinyo K, Evans S, Campbell T, Price R, Tripathy S, Kumarasamy N, La Rosa A, et al. Improved Neuropsychological and Neurological Functioning Across Three Antiretroviral Regimens in Diverse Resource-Limited Settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study. Clin Infect Dis. 2012;55(6):868-76. PMID: 22661489. PMCID: PMC3491853.

14. Soria J, Bull M, Mitchell C, La Rosa A, et.al. Transmitted HIV resistance to first-line antiretroviral therapy in Lima, Peru. AIDS Res Hum Retroviruses. 2012; 28(4):333-8. PMID: 21819256. PMCID: PMC3316114.

Completed Research Support

1 R01 AI071212-01A1 (Frenkel) 04/01/06-03/31/11
NIH
“Mechanism/predictors of genital/rectal HIV shedding during ART w/plasma <50c/mL”
By characterizing the viral load and genetics in blood, genital tract and rectum over time, this study aims to determine the rate of discordant shedding of virus in the blood plasma and genital tract/rectal; determine the epidemiological factors associated with discordant shedding; and provide further insight into the pathogenesis of expression of virus from activation of latent provirus versus full-cycles of replication with selection of drug-resistant virus
Role: Co-Principal Investigator

Biography

As a Site Leader, in the last six years has supported the development of training of patients and staff on-site service Clinical Research San Miguel 11302, which meets the standards rigorously U.S. NIH for sponsored clinical research. The CRS provides access to a wide spectrum of the population, including high-risk men who have sex with men and transgender women, HIV-infected persons, the population at risk male and female in general, people infected and affected by tuberculosis, and other hard-to reach populations. This scenario provides a unique opportunity to continue to support the development of scientific research agenda DAIDS.

In addition, during the past 12 years, I have contributed to the development and implementation of the research agenda scientific DAIDS through participation in ACTG HVTN scientific committees and working groups and teams, ACTG protocol, and the Working Group HANC Sciences Behavior. Also, I have been conducting clinical studies, as HVTN 914 Protocol Chair, Co-Chair of the RPT Protocol 017 and Co-Director of iPrEx Study. My scientific and management experience, increase your proposal.

I agree with my full commitment to supporting the overall structure and operation of the unit PERU IMPACTA clinical trials and serve in my role as leader of the CRS site San Miguel.

Positions and Honors

Experience and Professional Memberships

Honors

Selected peer-reviewed publications 

1. Bautista CT, Sanchez JL, Montano SM, Laguna-Torres VA, Lama JR, Kusunoki L, Manrique H, Acosta J, Montoya J, Tambare AM, Avila MM, Vinoles J, Aguayo N, Olson JG, Carr JK. Seroprevalence of and risk factors for HIV-1 infection among South American men who have sex with men. Sex Transm Infect. 2004;80(6):498-504. PMID: 15572623.

2. Grant RM, Buchbinder S, Cates W Jr, Clarke E, Coates T, Cohen MS, Delaney M, Flores G, Goicochea P, Gonsalves G, Harrington M, Lama JR, MacQueen KM, Moore JP, Peterson L, Sanchez J, Thompson M, Wainberg MA. AIDS. Promote HIV chemoprophylaxis research, don't prevent it. Science. 2005; 309(5744):2170-1. PMID: 16195446.

3. Grant RM, Moore JP, Clarke E, Lama JR, Cates W, Coates T, Cohen MS, Delaney M, Wainberg MA, Levy V, McConnell J, MacQueen KM. HIV research and access to treatment. Science 2006; 311 (5758): 175-6.

4. Lama JR, Sanchez J, Suarez L, Caballero P, Laguna A, Sanchez JL, Whitthington WL, Celum C, Grant RM. Linking HIV and antiretroviral drug resistance surveillance in Peru: A model for a third-generation HIV sentinel surveillance. J Acquir Immune Defic Syndr 2006; 42(4):501-5. PMID: 16773026.

5. Lama JR, Lucchetti A. Suarez L, Laguna-Torres VA, Guanira JV, Pun M, Montano SM, Celum CL, Carr JK, Sanchez J, Bautista CT, Sanchez JL. Association of Herpes Simplex Virus Type 2 infection and syphilis with Human Immunodeficiency Virus infection among men who have sex with men in Peru. J Infect Dis. 2006; 194(10):1459-66. PMID: 17054077.

6. Sanchez J, Lama JR, Kusunoki L, Manrique H, Goicochea P, Lucchetti A, Rouillon M, Pun M, Suarez L, Montano S, Sanchez JL, Tabet S, Hughes JP, Celum C. HIV-1, sexually transmitted infections, and sexual behavior trends among men who have sex with men in Lima, Peru. J Acquir Immune Defic Syndr. 2007; 44(5):578-85. PMID: 17279049.

7. Cleghorn F, Pape JW, Schechter M, Bartholomew C, Sanchez J, Jack N, Metch BJ, Hansen M, Allen M, Cao H, Montefiori DC, Tomaras GD, Gurunathan S, Eastman DJ, do Lago RF, Jean S, Lama JR, Lawrence DN, Wright PF. Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120. J Acquir Immune Defic Syndr 2007; 46(2):222-30. PMID: 17693888.

8. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PG, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 2008; 372(9653):1881-93. PMID: 19012954. PMCID: PMC2721012.

9. Sanchez J, Lama JR, Peinado J, Paredes A, Lucchetti A, Russell K, Kochel T, Sebastian JL. High HIV and ulcerative sexually transmitted infection incidence estimates among men who have sex with men in Peru: awaiting for an effective preventive intervention. J Acquir Immune Defic Syndr. 2009;51 Suppl 1:S47-51. PMID: 19384102.

10. Lama JR, Lucchetti A, Cabezas C, Suarez-Ognio L, Sanchez J. Lack of evidence of Hepatitis C and HIV co-infection among men who have sex with men in Peru. Am J Trop Med Hyg. 2009; 81(1):184-6. PMID: 19556587. PMCID: PMC3500390.

11. Lama JR, Agurto HS, Guanira JV, Ganoza C, Casapia M, Ojeda N, Ortiz A, Zamalloa V, Suarez-Ognio L, Cabezas C, Sanchez JL, Sanchez J. Hepatitis B infection and association with other sexually transmitted infections among men who have sex with men in Peru. Am J Trop Med Hyg 2010; 83(1):194–200. PMID: 20595501. PMCID: PMC2912599.

12. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Eng J Med. 2010; 363(27):2587-99. PMID: 21091279. PMCID: PMC3079639.

13. Havlir DV, Kendall MA, Ive P, Kumwenda J, Swindells S, Qasba SS, Luetkemeyer AF, Hogg E, Rooney JF, Wu X, Hosseinipour MC, Lalloo U, Veloso VG, Some FF, Kumarasamy N, Padayatchi N, Santos BR, Reid S, Hakim J, Mohapi L, Mugyenyi P, Sanchez J, Lama JR, Pape JW, Sanchez A, Asmelash A, Moko E, Sawe F, Andersen J, Sanne I, M.D., for the AIDS Clinical Trials Group Study A5221. Timing of Antiretroviral Therapy for HIV-1 Infection and Tuberculosis. N Engl J Med. 2011; 365(16):1482-91. PMID: 22010914. PMCID: PMC3327101.

14. Mayer KK, Bekker LG, Stall R, Grulich AE, Colfax G, Lama JR. Comprehensive clinical care for men who have sex with men: an integrated approach. Lancet. 2012; 380(9839):378-87. PMID: 22819653.

15. Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, M. Casapía M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallás EG, Grant RM, Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci. Transl. Med. 2012;4(151):151ra125. PMID: 22972843.

Completed Research Support

U01 AI064002 – (Grant) 08/15/05 – 01/31/11
US NIH/NIAID
“Chemoprophylaxis for HIV Prevention in Peruvian Men”
Role: Co-Chair

5 D43 TW008069-02 (Sanchez) 04/01/09– 03/31/11
A Step Forward for Latin American AIDS Research and Training Program (LAARTP)
To establish a curriculum on HIV/AIDS in order to provide specialized training on clinical research in the Latin American region
Role: Executive Director

Biography

I am Medical Doctor from the Universidad Nacional Mayor de San Marcos and specialist in Tropical Medicine and Infectious Diseases title from the Universidad Peruana Cayetano Heredia, with nine years of experience in Clinical Trials and fourteen years of experience in Infectious diseases and Sexual Transmitted Diseases, HIV/AIDS. Over the past few years, I have worked as Director, Co-Investigator and Principal Investigator in the Asociacion Civil Impacta Salud y Educacion in several DAIDS and University of Washington sponsored clinical trials. Between 2009 and 2011, I have been the 11302 CRS site leader of the IMPACTA Peru Clinical Trial Units.  I have also conducted several pharmaceutical sponsored trials.  I am currently the investigator of record for the studies of the AIDS Clinical Trials Network (ACTG): A5225, A5264, and A5278. I endorse my full commitment to support the overall structure and function of the IMPACTA PERU Clinical Trials Unit as Investigator of the San Miguel CRS 11302.

Positions and Honors

Selected peer-reviewed publications 

1. Golden MR, Astete SG, Galvan R, Lucchetti A, Sanchez J, Celum CL, Whittington WL, Stamm WE, Holmes KK, Totten PA. Pilot study of COBAS PCR and ligase chain reaction for detection of rectal infections due to Chlamydia trachomatis. J Clin Microbiol, 2003;41(5): 2174-5. PMID: 12734272. PMCID: PMC154739.

2. Zuckerman RA, Whittington WL, Celum CL, Collis T, Lucchetti A, Sanchez JL, Hughes JP, Coombs RW. Factors associated with oropharyngeal human immunodeficiency virus shedding. J Infect Dis. 2003;188(1):142-5. PMID: 12825183.

3. Zuckerman RA, Whittington WL, Celum CL, Collis TK, Lucchetti AJ, Sanchez J, Hughes JP, Sanchez JL, Coombs RW. Higher concentration of human immunodeficiency virus RNA in rectal mucosa secretions than blood and seminal plasma among men who have sex with men independent of antiretroviral therapy. J Infect Dis. 2004;190(1):156-61. PMID: 15195255.

4. Lama JR, Lucchetti A, Suarez L, Laguna-Torres VA, Guanira JV, Pun M, Montano SM, Celum CL, Carr JK, Sanchez J, Bautista CT, Sanchez JL, Peruvian HIV Sentinel Surveillance Working Group. Association of Herpes Simplex Virus Type 2 Infection and Syphilis with Human Immunodeficiency Virus Infection among Men Who Have Sex with Men in Peru. J Infect Dis. 2006;194(10):1459-66. PMID: 17054077.

5. Zuñiga R, Lucchetti A, Galvan P, Sanchez S, Sanchez C, Hernandez C, Sanchez H, Frahm N, Linde C, Hewitt H,Hildebrand W, Altfeld M, Allen T, Walker B, Korber B, Leitner T, Sanchez J, Brander C. Relative Dominance of Gag p24-Specific Cytotoxic T Lymphocytes Is Associated with Human Immunodeficiency Virus Control. J Virol. 2006;80(6):3122-25. PMID: 16501126. PMCID: PMC1395458.

6. Sanchez J, Lama JR, Kusunoki L, Manrique H, Goicochea P, Lucchetti A, Rouillon M, Pun M, Suarez L, Montano S, Sanchez JL, Tabet S, Hughes JP, Celum C. HIV-1, Sexually Transmitted Infections, and Sexual Behavior Trends Among Men Who Have Sex With Men in Lima, Peru. J Acquir Immune Defic Syndr. 2007;44(5):578-585. PMID: 17279049.

7. Zuckerman RA, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Zuñiga R, Magaret AS, Wald A, Corey L, Celum C. Herpes simplex virus (HSV) suppression with valacyclovir reduces rectal and blood plasma HIV-1 levels in HIV-1/HSV-2-seropositive men: a randomized, double-blind, placebo-controlled crossover trial. J Infect Dis. 2007;196(10):1500-8. PMID: 18008230.

8. Baeten JM, Strick LB, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Margaret A, Wald A, Corey L, Celum C. Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial. J Infect Dis. 2008;198(12):1804-8. PMID: 18928378. PMCID: PMC2665183.

9. Frahm N, Nickle DC, Linde CH, Cohen DE, Zuniga R, Lucchetti A, Roach T, Walker BD, Allen TM, Korber BT, Mullins JI, Brander C. Increased detection of HIV-specific T cell responses by combination of central sequences with comparable immunogenicity. AIDS. 2008;22(4):447-56. PMID: 18301057.

10. Lama JR, Lucchetti A, Cabezas C, Suarez-Ognio L, Sanchez JL; Peruvian HIV Sentinel Surveillance Working Group. Lack of evidence of hepatitis C and HIV co-infection among men who have sex with men in Peru. Am J Trop Med Hyg. 2009;81(1):184-6. PMID: 19556587. PMCID: PMC3500390.

11. Sanchez J, Lama JR, Peinado J, Lucchetti A, Russell K, Kochel T, Sebastian JL. High HIV and ulcerative sexually transmitted infection incidence estimates among men who have sex with men in Peru: awaiting for an effective preventive intervention. J Acquir Immune Defic Syndr. 2009;51 Suppl 1:S47-51. PMID: 19384102. PMCID: PMC2725017.

12. Zuckerman RA, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Margaret A, Wald A, Corey L, Celum C. HSV suppression reduces seminal HIV-1 levels in HIV-1/HSV-2 co-infected men who have sex with men. AIDS. 2009;23(4):479-83. PMID: 19169140.

Completed research support

3 R01 AI071212-01A1 (Frenkel) 04/01/06-05/31/11
“Mechanism/predictors of genital/rectal HIV shedding during ART w/plasma <50c/mL”
By characterizing the viral load and genetics in blood, genital tract and rectum over time, this study aims to determine the rate of discordant shedding of virus in the blood plasma and genital tract/rectal; determine the epidemiological factors associated with discordant shedding; and provide further insight into the pathogenesis of expression of virus from activation of latent provirus versus full-cycles of replication with selection of drug-resistant virus
Role: Investigator

The characteristics of the epidemic of AIDS and STIs require the coordinated action of all those involved in combating these health problems. Much of the success of the programs and projects of research, prevention and control of AIDS / STI through the establishment of working relationships, coordination and technical cooperation between academic and scientific institutions, government agencies, donors, international agencies multisectoral, community groups base and NGOs.