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Lenacapavir for HIV prevention taken twice a year

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP

Phase 2 Interventional Gilead Sciences · NCT06513312

This study is testing if a new injectable HIV prevention drug called lenacapavir, given twice a year, works as well as the standard daily pill for people at high risk of getting HIV.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment262 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Locations14 sites (Bobigny and 13 other locations)
Trial IDNCT06513312 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of lenacapavir (LEN) as a pre-exposure prophylaxis (PrEP) for HIV by comparing its use to the standard treatment of emtricitabine/tenofovir disoproxil fumarate (F/TDF). Participants will receive either LEN injections or oral F/TDF and will be monitored for their adherence to the treatment, safety, and how the drug is processed in the body. The study focuses on individuals at high risk for HIV acquisition, assessing both the acceptability of the treatment options and their effectiveness in preventing infection.

Who should consider this trial

Good fit: Ideal candidates include cisgender men who have sex with men, transgender individuals, and nonbinary people at increased risk for HIV acquisition.

Not a fit: Patients who are not at increased risk for HIV or those who are already HIV positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, less frequent method of HIV prevention that may improve adherence and outcomes for at-risk populations.

How similar studies have performed: Other studies have shown promise in using long-acting injectable PrEP options, making this approach a potentially viable alternative to daily oral medications.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
* Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
* Increased likelihood of HIV acquisition as indicated by at least one of the following:

  1. Condomless sex with ≥ 2 partners in the past 6 months
  2. Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months
  3. Engagement in sex work or transactional sex in the past 12 months
  4. Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months
  5. Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
* Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.

  1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is \< 48 hours.
* Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr):

  * (140 - age in years) × (weight in kg) x (0.85 if female) = CLcr (mL/min) / 72 × (serum creatinine in mg/dL)

Key Exclusion Criteria:

* Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
* Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection).
* Current use of nPEP, unless the prescribed course will be completed prior to randomization.
* Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
* 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).
* Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Where this trial is running

Bobigny and 13 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 Pre-Exposure Prophylaxis of HIV Infection
Last reviewed 2026-06-13 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.