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Could a shot every 6 months replace daily HIV prevention pills?

NCT ID NCT06513312

Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new option for preventing HIV: a shot given under the skin every 6 months, called lenacapavir. It compares how well people stick with the shot versus taking a daily pill (Truvada). About 268 people at higher risk for HIV will take part. The goal is to see if the shot is easier to use, safe, and works as well as daily pills.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

268 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-exposure prophylaxis of HIV infection

Contacts and locations

Locations

  • APHP Bichat Claude-Bernard Hospital

    Paris, 75018, France

  • APHP Hopital Saint-Antoine

    Paris, 75012, France

  • Axess Sexual Health, Liverpool University Hospitals NHS Trust

    Liverpool, L7 8YE, United Kingdom

  • CHU Nice Archet

    Nice, 6202, France

  • Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster Hospital

    London, SW10 9NH, United Kingdom

  • Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 3EW, United Kingdom

  • Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust

    London, E11BB, United Kingdom

  • Homerton Healthcare NHS Foundation Trust, Homerton University Hospital

    London, E9 6SR, United Kingdom

  • Hopital Avicenne

    Bobigny, 93000, France

  • Hopital Europeen Marseille

    Marseille, 13006, France

  • Hopital Saint Louis - Assistance Publique des Hopitaux de Paris

    Paris, 75010, France

  • Manchester University NS Foundation Trust

    Manchester, M13 0FH, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.