CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 5,399 enrolled
Drug / intervention
F/TAF +3 moredrug
Likely dose
F/TAF 25 mgfrom 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.

Search/NCT02842086
NCT02842086Phase 3Active
CompareCT.gov

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Gilead Sciences·interventional·Posted Jul 22, 2016·Updated May 5, 2026

In Brief

A Phase 3 clinical trial evaluating F/TAF, F/TDF, and 2 other interventions for Pre-Exposure Prophylaxis of HIV-1 Infection. Active but no longer recruiting, targeting 5,399 participants across 93 sites in 11 countries.

Detailed Summary

The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-Exposure Prophylaxis of HIV-1 Infection
CountriesAustria, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3ActiveOverdue
2017201820192020202120222023202420252026
First PostedJul 22, 2016
Enrollment StartSep 2, 2016
Primary CompletionJan 31, 2019
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.9 years ago

Interventions

F/TAFdrug

200/25 mg tablet administered orally once daily

F/TDFdrug

200/300 mg tablet administered orally once daily

F/TAF Placebodrug

Tablet administered orally once daily

F/TDF Placebodrug

Tablet administered orally once daily