PITTSBURGH, SEPT. 16, 2009 Hopeful that some of the same antiretroviral (ARV) drugs used to treat HIV infection can also prevent it, researchers from the Microbicide Trials Network have enrolled the first participants into a new, large-scale clinical trial testing two approaches of the strategy in women.
The VOICE Study Vagina and Oral Interventions to Control the Epidemic will help determine whether applying a vaginal microbicide gel containing an ARV every day or taking an oral ARV tablet once a day can reduce a woman's risk of acquiring HIV.
While the study's primary aim is to evaluate the safety and effectiveness of the two regimens, an important question VOICE will also address is which of the two the tablet or the gel women will actually be more inclined to use. It is the first HIV prevention trial testing these two different approaches in the same study and the first effectiveness trial of a microbicide in which women use the gel every day instead of only at the time of sex.
Up to 5,000 women will be enrolled in VOICE at clinical trial sites in Uganda, South Africa, Zambia and Zimbabwe. Pending government approval, the study may also be conducted in Malawi. The Spilhaus Clinical Research Site at the University of Zimbabwe-University of California-San Francisco (UZ-UCSF) Clinical Trials Unit in Harare, began enrolling trial participants this week.
VOICE is being conducted under the leadership of the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), which is based at the University of Pittsburgh and Magee-Womens Research Institute.
"The HIV prevention field has not been without its share of disappointments. So, naturally we are excited that in VOICE we have not just one, but two promising approaches to evaluate. Hopefully, we'll find that ARVs, which helped turn the tide in the treatment of HIV, can be a prevention powerhouse, too," said Mike Chirenje, M.D., FRCOG, associate
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| Contact: Lisa Rossi rossil@upmc.edu 412-916-3315 Microbicide Trials Network Source:Eurekalert |