Microbicide Trials Network

MTN-003

Details

Protocol Title: 
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
DAIDS Protocol ID: 
10622
Status: 
Closed to Follow Up

Protocol Chair(s)

Zvavahera Chirenje (Protocol Co-Chair)
Jeanne Marrazzo (Protocol Co-Chair)

Description

The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic –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 is 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 enroll 5,000 women at various study sites in Africa.

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of Child Health and Human Development

US National Institute of Mental Health

US National Institutes of Health

Co-Sponsors:

CONRAD, Gilead Sciences, Inc.

Study Design:

Phase 2B, five-arm, double-blinded, placebo-controlled, multi-site, randomized, controlled trial