clinical trial · NCT07047716
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Gilead Sciences·phase3·recruiting·n = 350
HIV Pre-exposure ProphylaxisLenacapavir InjectionLenacapavir Tablet
brief summary
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.
started
Jul 22, 2025
primary completion
Sep 1, 2028
completion
Sep 1, 2028
last updated
Mar 4, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol