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
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
5,399actual
Sites
93
Countries
Austria, Canada, Denmark +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2016-09-02 | actual | When the study began enrolling |
| Primary completion | 2019-01-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2016-07-22 | estimated | When this record first appeared on the registry |
| Results posted | 2020-03-17 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pre-Exposure Prophylaxis of HIV-1 Infection
Interventions
- Drug: F/TAF — also filed as Descovy®
- Drug: F/TDF — also filed as Truvada®
- Drug: F/TAF Placebo
- Drug: F/TDF Placebo
Primary outcome
what the primary-completion date above is the date OFIncidence of HIV-1 Infection Per 100 Person Years (PY)
measured When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-10-19 · 7.8 MB · Prot_003.pdf
Statistical Analysis Planposted 2019-12-11 · 2.2 MB · SAP_002.pdf
Publications
- PMID 32711800 — reports results
- PMID 39008999 — linked by the registry
- PMID 38312459 — linked by the registry
- PMID 37969014 — linked by the registry
- PMID 34197772 — linked by the registry
- PMID 34021709 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · GILD's whole pipeline · Catalyst calendar · Every registered study · What changed