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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

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Trial Profile

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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2026

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At a glance

  • Drugs Emtricitabine/tenofovir alafenamide (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms DISCOVER
  • Sponsors Gilead Sciences

Most Recent Events

  • 08 Sep 2026 Status changed from active, no longer recruiting to discontinued. Reason the study was stopped: Following review of accumulated safety data from DISCOVER and real-world use of F/TAF, the sponsor determined that the long-term safety of F/TAF had been demonstrated and no further safety monitoring within the study was required.
  • 17 Jul 2026 This trial has been completed in Ireland, Denmark, Spain, Italy, France, and Germany.
  • 05 May 2026 Planned End Date changed from 1 Sep 2027 to 1 Jul 2026.

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