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The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)

NCT01327651 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2025-03-27

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Daily dosing

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

DRUG

Time-driven dosing

TDF/FTC twice weekly with a post-exposure dose

DRUG

Event-driven dosing

TDF/FTC as needed with a post exposure dose

Sponsors & Collaborators

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Robert M. Grant, MD, MPH · University of California, San Francisco

  • Frits van Griensven, PhD, MPH · School of Medicine, University of California at San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-12-31
Completion
2014-12-31
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327651 on ClinicalTrials.gov