The overarching goal of the proposed renewal of the PERU CTU is to continue contributing to the design and implementation of the NIH HIV/AIDS clinical trial networks research agenda, across the continuum from prevention to treatment of HIV and tuberculosis (TB). It builds upon 19 years of experience and over $110 million of NIH investment to establish a comprehensive clinical and laboratorial infrastructure for designing and implementing network research studies, including those from the HVTN, HPTN, ACTG, MTN and INSIGHT, as well as several non-network clinical trials. The consortium is led by Asociacion Civil Impacta Salud y Educacion (IMPACTA) and is also composed by the Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales (CITBM), the Asociacion Civil Selva Amazonica (ACSA) and the Asociacin Via Libre. Multiple principal investigators are Dr. Jorge Sanchez (based at CITBM) and Dr. Alberto La Rosa (based at IMPACTA) and supported by a cadre of experienced researchers and promising junior investigators. A consolidated three-dimensional (3D) matrix organizational structure integrates organizational functions (CTU governance and Clinical Research Sites, CRSs), support functions (through four resource units) and production functions (local teams leading specific trials). This 3D matrix interplay allows for operations that are cohesive, synergistic, integrated, transparent, flexible, responsive and adaptable. It provides efficient utilization of infrastructure and resources, avoiding redundancies, providing centralized services, sharing strategies and optimizing cost containment. Two mature Community Advisory Boards are the cornerstone for successful community participation in all stages of research. The PERU CTU proposes to continue conducting the networks research agenda at five CRSs: ACSA (HPTN, HVTN), Barranco (HVTN, ACTG), CITBM (HPTN, HVTN), San Miguel (ACTG, HPTN), and Via Libre (HVTN, HPTN). The specific areas of research proposed for the next grant cycle have been chosen considering both the networks research priorities and our CRS strengths. In each area, there is a track record of significant accomplishments and great potential for future contributions. The CTU aims to: 1) evaluate individual and combination vaccine and non-vaccine HIV prevention interventions among men who have sex with men and transgender women; 2) evaluate novel therapeutic interventions targeting HIV and strategies to address toxicities, drug-drug interactions, and comorbidities; 3) improve the prevention and treatment of tuberculosis; 4) maintain the highest standards of resource management for efficient and timely implementation of clinical trials; and 5) continue building relationships and effective communications with the Peruvian community and stakeholders promoting good participatory practices in clinical trials. These feasible aims, our increasing capacity to conduct clinical trials and our ability to adapt to challenges, uniquely position the PERU CTU to continue contributing towards an HIV/AIDS- and TB-free generation.

Public Health Relevance

The PERU CTU proposes to continue contributing to the design and implementation of the DAIDS scientific research agenda to decrease new HIV infections, reduce HIV associated morbility and mortality, and ultimately end the HIV epidemic. Given the high incidence of tuberculosis in the country and the high burden of drug resistant strains, the PERU CTU is in an advantageous position to continue contributing to the design and implementation of clinical trials evaluating interventions to control the tuberculosis epidemic. Our strategy is to focus on vulnerable populations in resource limited settings, utilizing existing research infrastructure that includes state of the art laboratories, experienced personnel, with active participation from community stakeholders.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Guerra, Maria Isabel
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Asociacion Civil Impacta Salud Y Educacn
Zip Code
Swindells, S; Gupta, A; Kim, S et al. (2018) Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis 22:1016-1022
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women. AIDS 32:583-593
De Boni, Raquel B; Zheng, Lu; Rosenkranz, Susan L et al. (2016) Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend 159:174-80
La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58
Robertson, K; Jiang, H; Evans, S R et al. (2016) International neurocognitive normative study: neurocognitive comparison data in diverse resource-limited settings: AIDS Clinical Trials Group A5271. J Neurovirol 22:472-8
Lemos, M P; Karuna, S T; Mize, G J et al. (2016) In men at risk of HIV infection, IgM, IgG1, IgG3, and IgA reach the human foreskin epidermis. Mucosal Immunol 9:798-808
Lama, Javier R; Karuna, Shelly T; Grant, Shannon P et al. (2016) Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection. PLoS One 11:e0160487
Gross, Robert; Zheng, Lu; La Rosa, Alberto et al. (2015) Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial. Lancet HIV 2:e12-9
Firnhaber, Cynthia; Smeaton, Laura M; Grinsztejn, Beatriz et al. (2015) Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials 16:89-99
Podany, Anthony T; Bao, Yajing; Swindells, Susan et al. (2015) Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention. Clin Infect Dis 61:1322-7

Showing the most recent 10 out of 19 publications