PITTSBURGH, September 28, 2011 VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women daily use of one of two different ARV tablets or of a vaginal gel will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.
Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)'s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.
VOICE Vaginal and Oral Interventions to Control the Epidemic involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.
The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet an approach called oral pre-exposure prophylaxis, or PrEP and a vaginal gel in the same study. This design is important for determining how eac
|Contact: Lisa Rossi|
Microbicide Trials Network