FEM-PrEP

Status:Stopped Early
Phase:III
Principal Investigator(s):Lut Van Damme, MD, MS, PhD; Amy Corneli, PhD, MPH
Objective:Investigate the safety and effectiveness of once-daily oral TDF/FTC (Truvada) in preventing HIV among women at risk of becoming infected through sexual intercourse.This study was stopped early due to futility (poor adherence)Last updated August 10, 2022
Prevention Option(s):PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionDaily dosing
Mode of DeliveryTablet
ARMsExperimental
Results: Preexposure prophylaxis for HIV infection among African women.
Official Code: NCT00625404
Related Publications:
Sino-implant (II)® continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya
Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women
Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial
Trial Sponsors: Bill & Melinda Gates Foundation, FHI 360, USAID
Start Date
End Date
May 31, 2009
January 31, 2013
Enrollment:2,120
Age range: 18 Years ↔ 35 Years
Population:Cisgender Women