This is an application to renew a Clinical Trials Unit (CTU) in Botswana that will conduct research related to adult and pediatric HIV therapeutic strategies; interventions to address HIV-associated infections/conditions in pediatric and maternal populations; treatment and prevention of tuberculosis in adults (including pregnant women) and children with and without HIV; and integrated HIV prevention strategies in pediatric and adult populations. These activities will occur through participation in three research networks: 1) the HIV/AIDS Adult Therapeutics Clinical Trials Network; 2) HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network, and 3) the HIV Prevention Clinical Trials Network. We will perform multi-center studies at our two established CRSs: one in Gaborone (all 3 networks), the capital city of Botswana, and the other in Molepolole (Maternal, Adolescent and Pediatric Therapeutics network only), the largest village in Botswana. We will thus work with both urban and village populations of all ages and of both sexes. The primary objective of this proposal is therefore to renew a CTU in Botswana that will participate in and contribute to the following high-impact areas of research: ? Novel and durable treatments for HIV in adults (including pregnant women) and children ? Strategies to induce ART-free HIV remission (or eradication) in adults and children ? Treatment and prevention of HIV-related complications and co-infections in adults and children ? New treatments / modalities and prevention approaches for tuberculosis in adults and children ? HIV prevention strategies, including pre-exposure prophylaxis and integrated prevention approaches Within each of these research areas, this CTU will contribute significantly to: ? Enrolling participants into and conducting high-quality clinical research studies, ? Participating in network activities, including protocol teams and scientific / resource committees, and ? Conceiving and proposing new, relevant, high-impact studies in priority areas

Public Health Relevance

The Botswana Clinical Trials Unit will develop and study strategies for preventing and treating HIV infection and HIV-related illnesses, including tuberculosis, that are relevant to the severe HIV epidemic in sub-Saharan Africa and elsewhere. This will include studies of novel and durable HIV treatment in HIV-infected adults, including pregnant women, and children; strategies to induce antiretroviral-free HIV remission (or eradication) in adults and children; new treatments and prevention approaches for tuberculosis in adults, including pregnant women, and children; and HIV prevention strategies, including pre-exposure prophylaxis and integrated prevention approaches.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1)
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Pouliot, Eileen M
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Harvard University
Schools of Public Health
United States
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Gregson, John; Kaleebu, Pontiano; Marconi, Vincent C et al. (2017) Occult HIV-1 drug resistance to thymidine analogues following failure of first-line tenofovir combined with a cytosine analogue and nevirapine or efavirenz in sub Saharan Africa: a retrospective multi-centre cohort study. Lancet Infect Dis 17:296-304
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