VOICE study, a major HIV prevention trial for women, is launched i... (gel contains the activated form of the s...)

VOICE study, a major HIV prevention trial for women, is launched in Zimbabwe

Date:9/16/2009

gel, contains the activated form of the same ingredient in the tenofovir oral tablet. It is among a newer class of candidate microbicides substances intended to reduce or prevent the sexual transmission of HIV and other sexually transmitted infections when applied topically inside the vagina or rectum with specific activity against HIV.

Women in VOICE are randomly assigned to one of five study groups. Two groups will apply gel every day either tenofovir gel or a placebo gel with no active ingredient. Three groups will be assigned to daily tablet regimens, taking either tenofovir, Truvada or a placebo tablet. Because the study is blinded, neither the participants nor the researchers will know who is in which gel or tablet group. Women will use the same product every day the entire time they are in the study, which is expected to be an average of 22.5 months.

All participants will receive regular HIV testing and risk-reduction counseling, condoms, and testing for sexually transmitted infections (STIs). Staff will refer any participant who acquires HIV or an STI during the study to appropriate treatment and care in her community.

Researchers at the Uganda and Zimbabwe sites are also conducting a companion study called VOICE B, or the Bone Mineral Density Sub-study. VOICE B will involve about 300 women who have been randomized to the oral tablet groups to determine the potential effects, if any, that the oral ARVs may have on bone health in HIV-negative women.

Both studies were designed according to the most rigorous international medical practice and ethical standards and include numerous measures, beginning at the site level, intended to protect the safety and well-being of participants. All women participating in VOICE and VOICE B will provide written informed consent through a process that ensures they understand the procedures, as well as possible risks and benefits of the study. Safety will be monitored closely throughout th
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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