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

Conditions

• HIV Pre-exposure Prophylaxis

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Lenacapavir Injection — DRUG
  Administered intramuscularly
• Lenacapavir Tablet — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Jul 22, 2025

Status verified

Mar 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

350 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Lenacapavir (LEN)
  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.
• Experimental: LEN Extension Phase
  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.

Primary Outcome Measure

Plasma LEN Ctrough at Week 52 [ Time Frame: Week 52 ]

Central Contacts

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (31)

Find similar trials in Birmingham, AL

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