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
- Enrolling
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 4,200 women at various study sites in Africa.
Sites
- Bothas Hill Clinical Research Site
- Umkomaas Clinical Research Site
- College of Medicine - Johns Hopkins University Research Project at Queen Elizabeth Central Hospital
- Makerere University - Johns Hopkins University Research Collaboration
- Seke South Clinical Research Site
- Spilhaus Clinical Research Site
- R.K. Khan Hospital
- Zengeza 3 Clinic
- Isipingo CRS
- Overport CRS
- CAPRISA Aurum CRS
- RHRU Research and Training Centre CRS
- CAPRISA eThekwini CRS
- Tongaat CRS
- Verulam CRS
- Soweto MTN CRS
Email Groups
- MTN-003 (VOICE) Investigator Calls
- MTN-003 (VOICE) Newsletter
- MTN-003 ACASI User Support
- MTN-003 Accrual
- MTN-003 Adherence
- MTN-003 Investigators
- MTN-003 Pharmacists
- MTN-003 Protocol Deviations
- MTN-003 Protocol Safety Review Team
- 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
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