At a glance
ClinicalIndex Comparison RecordN/ACompleted· 557 enrolled
Drug / intervention
FTC 200 mg/TDF 300 mg fixed-dose combination tabletdrug
Likely dose
FTC 200 mg/TDF 300 mg fixed-dose combination tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 4, 2012·Updated Nov 5, 2021
In Brief
A clinical study evaluating FTC 200 mg/TDF 300 mg fixed-dose combination tablet for HIV Infections. Completed, enrolled 557 participants across 3 sites.
Detailed Summary
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartOct 2012
Primary CompletionFeb 2015
TodayJul 2026
First PostedJul 4, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.0 years ago
Interventions
FTC 200 mg/TDF 300 mg fixed-dose combination tabletdrug
Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.