Rationale: Pre-exposure prophylaxis is a strategy that aims to use antiretrovirals to reduce the risk of HIV infection. Studies in non-human primates have shown that both oral and topical applications of ARVs before exposure reduce risk or completely prevent infection with challenge by an HIV-like virus that causes disease in monkeys.
TDF/FTC (marketed under the name Truvada) is an antiretroviral used by HIV-positive people as part of highly active antiretroviral therapy.
Study question(s): This study is examining the safety and efficacy of a PrEP strategy (once-daily TDF/FTC) in reducing the risk of HIV infection in women whose primary risk factor is vaginal sex.
Participants: 1,950 women
Countries: Kenya, South Africa, Tanzania
Trial sponsors and collaborators: Bill & Melinda Gates Foundation, Family Health International (FHI), Gilead Sciences, United States Agency for International Development (USAID)
When can we expect results? Study's data review committee determined that the trial would not be able to answer the question of whether the study drug decreased risk of HIV infection among HIV-negative women at risk via sexual transmission. The study will be discontinued. Final results Q4 2011.
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