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Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

Study acronym: PURPOSE 365
StatusActive, Not Recruiting
PhasePhase 3
Started2025-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status v11
Re-verified, no change to tracked fields
2026-06-17
Study Status, Study Design, Contacts/Locations v10
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment targetestimated 350→confirmed 339
Study sitesdetails revised at 31 of 31 sites
2026-03-02
Study Status, Study Design, Arms and Interventions v9
Enrollment target300→350
2026-01-08
Study Status, Contacts/Locations v8
Study sites30→31
2025-12-17
Study Status, Contacts/Locations v7
Study sites26→30
Show 6 earlier versions
2025-11-21
Study Status, Contacts/Locations v6
Study sites21→26
2025-11-10
Study Status, Contacts/Locations v5
Study sites11→21
2025-10-16
Study Identification, Study Status, Contacts/Locations v4
Start date2025-07-25→2025-07-22
Study sites8→11
2025-09-09
Study Status, Contacts/Locations v3
Study sites3→8
2025-08-14
Not Yet Recruiting→Recruiting Study Status, Study Design, Arms and Interventions, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07→confirmed 2025-07-25
Study sites0→3
2025-07-07
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2025-06-24
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.
Trial Details
NCT Number NCT07047716
Lead Sponsor Gilead Sciences
Conditions HIV Pre-exposure Prophylaxis
Enrollment 339 participants
Start Date 2025-07-22
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-28