CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 622 enrolled
Drug / intervention
Daily dosing +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01327651
NCT01327651Phase 2Completed
CompareCT.gov

The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)

HIV Prevention Trials Network·interventional·Posted Apr 1, 2011·Updated Mar 27, 2025

In Brief

A Phase 2 clinical trial evaluating Daily dosing, Time-driven dosing, and 1 other intervention for HIV Infections. Completed, enrolled 622 participants across 3 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.3 years ago

Interventions

Daily dosingdrug

A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.

Time-driven dosingdrug

TDF/FTC twice weekly with a post-exposure dose

Event-driven dosingdrug

TDF/FTC as needed with a post exposure dose