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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
Randomized
Double-blind
Arms and Assigned Interventions
Description
Daily dosing
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Tablet
ARMs
Placebo Comparator
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
FHI 360, USAID, Bill & Melinda Gates Foundation
Product Developers
Gilead Sciences, Inc.
May 2009
January 2013
Date of Enrollment Completion
August 1, 2012
Enrollment
2 120
18
Years
35
Years
Population
Women
Sites

Bondo Clinic, Bondo District Hospital

Bondo, Nyanza
Kenya

Setshaba Research Centre

Shoshanguve
South Africa

Josha Research Center

Josha, Bloemfontein
South Africa

Arusha Clinic, Levolosi Health Cente

Arusha
United Republic of Tanzania