Trial: Study of behavioral, clinical safety and adherence of Daily Tenofovir Disoproxil Fumarate and Emtricitabine (Truvada ®) for the prevention of HIV infection in heterosexually active young adults in botswana

The CDC is submitting an amendment to the trial which if approved would modify the primary research questions for the study from that of efficacy to other critical research objectives related to behavioral and clinical safety, as well as adherence. For more information read our Advocates' Network explanation of the rationale behind these changes.

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 reduces risk or completely prevents 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 pre-exposure prophylaxis strategy (once-daily Truvada ®, a combination of the drugs tenofovir and emtricitabine) in reducing the risk of HIV infection in men and women whose primary risk factor is vaginal sex.

Participants: 1,200 HIV-negative heterosexual men and women

Country: Botswana

Trial sponsors and collaborators: US Centers for Disease Control and Prevention (CDC)

When can we expect results? 2011

To learn more visit:

http://www.cdc.gov/hiv/prep/resources/factsheets/botswanatdf2.htm

http://www.cdc.gov/hiv/resources/factsheets/prep.htm

http://clinicaltrials.gov/ct2/show/NCT00448669?term=CDC+4940&rank=1