MTN 003 (VOICE)

Safety and effectiveness of Tenofovir 1% Gel,Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/ Tenofovir Disoproxil Fumarate Tablet for the prevention of HIV infection in women

Sponsors:
Division of AIDS
US National Institute of Allergy and Infectious Diseases (NIAID)
US National Institutes of Health (NIH)

Protocol Summary:
The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – was a Phase 2B, five-arm, double-blinded, placebo-controlled, multisite, randomized, controlled trial, and is the first study to compare the safety and efficacy of oral versus topical pre-exposure prophylaxis (PrEP) for prevention of sexual transmission of HIV. VOICE wass designed as a five-arm, double-blinded study in which women are first randomized to receive either gel or oral PrEP, and then within each group, randomly assigned to either tenofovir 1% topical gel or placebo gel; or to oral tenofovir(tenofovir disoproxil fumarate), oral Truvada (emtricitabine/tenofovir disoproxil fumarate) or oral placebo. The study will enrolled over 5,000 women at various study sites in Africa.

Years: 2009 – 2012

Investigator: Z.M. Chirenje, MD, FRCOG

Locations: Spilhaus, Seke South, and Zengeza CRSs

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