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Status
Completed
Phase
II
Principal Investigator(s)
Robert M. Grant, MD, MPH, University of California, San Francisco
Objective
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based.
Prevention Option(s)
PrEP
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Participants will receive oral TDF/FTC daily.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Participants will receive oral TDF/FTC twice weekly with a post-exposure dose.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Results
Official Code
Related Publications
Trial Sponsors
DAIDS, HPTN, NIMH
Product Developers
Gilead
August 2011
December 2014
Enrollment
540
18
Years
Population
MSM
Sites
Desmond Tutu Clinical Research Center
Cape Town, South Africa
South Africa
Harlem Prevention Center
New York, NY
United States of America
Silom Community Clinic
Bangkok, Ratchathewi
Thailand