MTN 003 (VOICE)

Status:Completed
Phase:IIb
Principal Investigator(s):Zvavahera M. Chirenje, MD, FRCOG; Jeanne Marrazzo, MD, MPH
Objective:To determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF or oral TDF/FTC compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.   Results: None of the drug regimens evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low.
Prevention Option(s):Microbicides, PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionDaily dosing
Mode of DeliveryTablet
ARMsExperimental
DescriptionDaily dosing
Mode of DeliveryTablet
ARMsExperimental
DescriptionDaily dosing
Mode of DeliveryGel
ARMsExperimental
Results: Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women
Official Code: NCT00705679
Trial Sponsors: CONRAD, Gilead, MMH, MTN, NIAID, NICHD
Start Date
End Date
August 1, 2009
August 1, 2012
Enrollment:5,029
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women