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Studies

Study Description
Current and Planned Studies
HPTN 035 A multi-center clinical trial evaluating the safety and effectiveness of two different candidate microbicides, BufferGel® and PRO 2000, in 3,100 sexually active HIV-negative women at seven sites in Africa and the United States. Results are expected in 2009.
MTN-001 A Phase II trial directly comparing the tablet and vaginal gel formulations of the antiretroviral drug tenofovir, looking at women’s adherence to and acceptance of three daily regimens – tenofovir gel, tenofovir tablet and the two together – and how the drug is absorbed by and distributed in the body.
MTN-002 The first study of a candidate topical microbicide in pregnant women that seeks to understand if and to what extent pregnancy affects how the body absorbs the active drug in the antiretroviral-based candidate microbicide tenofovir gel and whether the drug can be transferred to the fetus.
MTN-003 (VOICE) The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic –is evaluating the safety, effectiveness and adherence of two approaches – taking an antiretroviral pill once a day or applying a vaginal microbicide gel on a daily basis –for preventing sexual transmission of HIV in women. The study will involve 4,200 women and begin early 2009.
MTN-004 A study evaluating the safety, acceptability and ease of use of the microbicide candidate VivaGel™ in sexually active, HIV-negative women ages 18 to 24. Enrollment has been paused to allow for a redesign of the protocol and is expected to resume in July 2008.
MTN-015 A long-term, observational study that seeks to understand the nature of HIV progression and treatment response in women who became infected while participating in an MTN trial of a topical microbicide or oral antiretrovirals as pre-exposure prophylaxis.
Completed Studies
HPTN 059 The trial, now complete, assessed the safety and acceptability of the antiretroviral-based candidate microbicide tenofovir topical gel used either daily or before each act of sex in 200 HIV-negative women at three sites in India and the United States.