NCT02842086

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,399 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre-Exposure Prophylaxis of HIV-1 Infection

Interventions

Type	Name	Description
DRUG	F/TAF	200/25 mg tablet administered orally once daily
DRUG	F/TDF	200/300 mg tablet administered orally once daily
DRUG	F/TAF Placebo	Tablet administered orally once daily
DRUG	F/TDF Placebo	Tablet administered orally once daily

Timeline

• Start date: 2016-09-02
• Primary completion: 2019-01-31
• Completion: 2027-09-01
• First posted: 2016-07-22
• Last updated: 2025-11-13
• Results posted: 2020-03-17

Locations

93 sites across 11 countries: United States, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study