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Once-yearly lenacapavir injection for HIV prevention (PrEP)

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

Phase 3 Interventional Gilead Sciences · NCT07047716

This trial will test whether a once-yearly lenacapavir injection is safe and can prevent HIV in people who qualify for PrEP.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages16 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Locations31 sites (Birmingham, Alabama and 30 other locations)
Trial IDNCT07047716 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study administers intramuscular lenacapavir every 12 months to people eligible for HIV PrEP and measures how the drug is absorbed, distributed, metabolized, and cleared. Participants may also receive oral lenacapavir tablets per protocol and will undergo regular HIV testing and safety monitoring. The primary focus is on pharmacokinetics, tolerability, and safety of annual dosing. Enrollment targets people aged 16 and older with recent receptive anal or vaginal sex and other PrEP risk factors who are HIV-negative at screening.

Who should consider this trial

Good fit: Ideal candidates are people aged 16 or older who are HIV-negative, meet criteria for PrEP (recent receptive anal or vaginal sex with risk factors), and can attend study visits for injections and testing.

Not a fit: People who are HIV-positive, have acute or disqualifying chronic viral hepatitis, show current signs of acute HIV infection, or cannot travel to participating sites are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, a once-yearly injection could simplify PrEP, improve adherence, and reduce HIV infections compared with daily pills.

How similar studies have performed: Earlier-phase studies of long-acting lenacapavir and other long-acting PrEP agents have shown promising safety and durable drug levels, but once-yearly lenacapavir for PrEP is novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* At least 16 years of age at screening.
* Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:

  1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
  2. For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months
  3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
  4. Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
* Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.

Key Exclusion Criteria:

* Current signs or symptoms suggesting HIV infection
* Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
* Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
* Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV Pre-exposure Prophylaxis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.