Trial Profile

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP

Status: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 06 Apr 2026

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At a glance

Drugs Lenacapavir (Primary) ; Lenacapavir (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
Indications HIV-1 infections
Focus Therapeutic Use
Acronyms PURPOSE 5
Sponsors Gilead Sciences

15 Oct 2025 According to a Gilead Sciences media release, data from this trial will be presented at the 20th European AIDS Conference (EACS) to be held in Paris, France from October 15-18.
22 Jun 2025 Planned End Date changed from 1 Jul 2029 to 1 Dec 2028.
22 Jun 2025 Planned primary completion date changed from 1 Jan 2027 to 1 May 2026.

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