Email Updates

You are here

FEM-PrEP

Status
Completed
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. 

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
Trial Sponsors
FHI 360, USAID, Bill & Melinda Gates Foundation
Product Developers
Gilead Sciences, Inc.
May 2009
January 2013
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