Rationale: 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. The VOICE study is designed to look at safety and efficacy of both oral and topical ARV compounds. It is also comparing the safety and efficacy of single and dual drugs in oral form.
TDF and TDF/FTC are antiretrovirals used by HIV-positive people as part of combination treatment.
Study question(s): This study is designed to examine the safety and effectiveness of various PrEP strategies in reducing the risk of HIV infection in women whose primary risk factor is vaginal sex. Participants, all of whom will receive a standard prevention package, will also be randomly assigned to receive one of the following:
- oral PrEP (once-daily TDF and tenofovir gel)
- oral PrEP (once-daily TDF/FTC)
- topical tenofovir gel (once-daily application)
- placebo pill (once-daily)
- placebo gel (once-daily application)
Participants: 5,000 women
Countries: Malawi, South Africa, Uganda, Zimbabwe
Trial sponsors and collaborators: CONRAD, Gilead Sciences, Microbicide Trials Network (MTN), US National Institutes of Health (NIH)
When can we expect results? 2012
To learn more visit:
http://clinicaltrials.gov/ct2/show/NCT00705679?term=tenofovir+gel&rank=7