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VOICE study will continue as it considers what action to take after results of 2 trials
Date:7/13/2011

PITTSBURGH, July 13, 2011 Today, researchers from two major HIV prevention trials announced favorable results of an approach called oral pre-exposure prophylaxis, or PrEP. One of these trials, the Partners PrEP Study, has provided the strongest evidence yet of PrEP's effectiveness.

Information from both studies will need to be fully evaluated before it can be determined what impact they will have on another major trial that is ongoing. Investigators for VOICE Vaginal and Oral Interventions to Control the Epidemic, and the study's sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), hope to complete their evaluation as soon as possible. In the meantime, the five-arm study involving more than 5,000 women in sub-Saharan Africa will continue as currently designed.

PrEP involves the use of antiretroviral (ARV) drugs commonly used in the treatment of HIV by individuals who are not infected. In the Partners PrEP Study, researchers from the University of Washington and their collaborators in Uganda and Kenya, evaluated the safety and effectiveness of daily use of two ARVs tenofovir and Truvada, the brand name for a tablet combining tenofovir and emtricitabine among men and women in a discordant relationship with a partner who is HIV-positive. The study enrolled 4,758 serodiscordant couples.

There were 62 percent fewer HIV infections among participants assigned to take the ARV tenofovir daily compared to participants who took a placebo tablet, and 73 percent fewer infections among those who took Truvada. In statistical terms, the results leave little doubt they are not due to chance. However, the study was not able to say whether Truvada or tenofovir works better than the other in preventing HIV.

The results came to light during a review conducted by Partner PrEP's independent Data Safety and Monitoring Board (DSMB) just a few days ago, on July 10. T
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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