MTN 003 (VOICE)

February 13, 2014

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

MTN

Completed Study

Publication:

Marrazzo JM, Ramjee G, Richardson BA, et al. (2015) Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6): 509-18.

van der Straten A, Brown ER, Marazzo JM, et al. (2016) Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016 Feb 4;19(1):20642.

Akello CA, Bunge KE, Nakabiito C, et al. (2017) Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial. J Womens Health (Larchmt). 2017 Feb 17.

Chirenje ZM, Gudenacker HM, Richardson B, et al. (2017) Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Trams Dis. 2017 Mar;44(3):135-140.