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

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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