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: 3,900 women
Countries: Kenya, Malawi, South Africa, Tanzania, Zambia
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? 2012
To learn more visit:
http://clinicaltrials.gov/ct2/show/NCT00625404?term=FEM-PrEP&rank=1
http://www.prepwatch.org/pdf/Trials/FEMPrEP_Issue2_July09.pdf