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A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

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Trial Profile

A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2025

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At a glance

  • Drugs Lenacapavir (Primary) ; Lenacapavir (Primary)
  • Indications HIV infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms PURPOSE 365
  • Sponsors Gilead Sciences

Most Recent Events

  • 20 Aug 2025 Status changed from not yet recruiting to recruiting.
  • 02 Jul 2025 Status changed from planning to not yet recruiting.
  • 21 Mar 2025 New trial record

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