Details
Email Groups
- MTN-003 ACASI User Support
- MTN-003 Accrual
- MTN-003 Adherence
- MTN-003 Investigator Calls
- MTN-003 Investigators
- MTN-003 Lab
- MTN-003 Newsletter
- MTN-003 Pharmacists
- MTN-003 Protocol Deviations
- MTN-003 Protocol Safety Review Team
- MTN-003 Publication Committee
- MTN-003 Safety MD
- MTN-003 Safety Message Board
- MTN-003 Safety Reports
- MTN-003 Study Coordinators
- MTN-003 Study Management Team
- MTN-003 Study Monitoring Committee
Sites
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
