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A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

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Trial Profile

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2025

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At a glance

  • Drugs MK-8527 (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EXPrESSIVE-11
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 11 Aug 2025 Status changed from not yet recruiting to recruiting.
  • 14 Jul 2025 According to Merck Sharp & Dohme media release, company announced initiation of initiation of the EXPrESSIVE Phase 3 clinical trials. decision to initiate the Phase 3 clinical trial program was supported by the results of a double-blind, multicenter, Phase 2 trial MK-8527-007 and company will begin enrolling in August 2025.
  • 07 Jul 2025 New trial record

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