HPTN 067 (ADAPT)

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:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive oral TDF/FTC daily.
Mode of DeliveryTablet
ARMsExperimental
DescriptionParticipants will receive oral TDF/FTC twice weekly with a post-exposure dose.
Mode of DeliveryTablet
ARMsExperimental
DescriptionParticipants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Mode of DeliveryTablet
ARMsExperimental
Results: Press Release: HPTN 067 demonstrates high-risk populations adhere well to daily PrEP regimen
Official Code: NCT01327651
Related Publications:
CROI Abstract Poster: HPTN 067/ADAPT Cape Town: A comparison of daily and nondaily PrEP dosing in African women
HPTN Announcement: Daily Dosing May Foster More Sustained Use of PrEP by African Women to Prevent HIV
Trial Sponsors: DAIDS, HPTN, NIMH
Start Date
End Date
August 1, 2011
December 1, 2014
Enrollment:540
Age range: 18 Years ↔ any
Population:Gay and Bisexual Men Who Have Sex with Men