A Phase 3 interventional study of Lenacapavir Injection and Lenacapavir Tablet in HIV Pre-exposure Prophylaxis, sponsored by Gilead Sciences. Active, not recruiting at 31 sites in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Prevention
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.
Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks: * LEN 3000 mg injection once on Day 1 * Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period Participant will receive additional oral LEN if IM injection are not available. If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks.
Drug: Lenacapavir Injection · Drug: Lenacapavir Tablet
Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase. Participants will receive oral LEN if IM injections are not available. If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks.
Drug: Lenacapavir Injection · Drug: Lenacapavir Tablet
Administered intramuscularly
Administered orally
Plasma LEN Ctrough at Week 52
Ctrough is defined as the concentration at the end of the dosing interval.
Time frame: Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Time frame: First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (up approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event
Time frame: First dose up to 30 days post last dose (approximately 3 years)
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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