Clinical Trial

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

Study acronym: DISCOVER
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 30 amendments
This ClinicalTrials.gov record has been amended 30 times since 2016-07-20; most recent amendment 2026-04-14.
Status change: Recruiting → Active, Not Recruiting 2017-07-11
Status change: Not Yet Recruiting → Recruiting 2016-09-16
Trial Details
NCT Number NCT02842086
Lead Sponsor Gilead Sciences
Conditions Pre-Exposure Prophylaxis of HIV-1 Infection
Enrollment 5,399 participants
Start Date 2016-09-02
Primary Completion 2019-01-31 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-05