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Yearly HIV prevention shot could change the game

NCT ID NCT07047716

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tests a new shot called lenacapavir, given once a year, to see if it can safely prevent HIV in people at risk. About 350 participants will receive the injection and be monitored for side effects and drug levels. If successful, this could offer a much more convenient option than daily pills or frequent injections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

339 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Sep 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

16 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: * 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.

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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.

HIV pre-exposure prophylaxis

Contacts and locations

Locations

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California, 94102, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Fenway Health

    Boston, Massachusetts, 02215, United States

  • Howard Brown Health Center

    Chicago, Illinois, 60613, United States

  • ICAP at Columbia University- Bronx Prevention Center

    The Bronx, New York, 10451, United States

  • Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center

    New York, New York, 10029, United States

  • Johns Hopkins Hospital - Clinical Research Unit

    Baltimore, Maryland, 21287, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Penn Prevention Unit

    Philadelphia, Pennsylvania, 19104, United States

  • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

    Philadelphia, Pennsylvania, 19107, United States

  • Ponce de Leon Center Clinical Research Site

    Atlanta, Georgia, 30303, United States

  • Ruane Clinical Research Group, Inc.

    Los Angeles, California, 90036, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Crofoot Research Center

    Houston, Texas, 77098, United States

  • The Hope Clinic of Emory University

    Atlanta, Georgia, 30030, United States

  • The ID Prevention Research Unit

    Miami, Florida, 33136, United States

  • UAB Sexual Health Research Clinic

    Birmingham, Alabama, 35233, United States

  • UCLA Clinic Care

    Los Angeles, California, 90035, United States

  • UCLA Vine Street Clinic

    Los Angeles, California, 90038, United States

  • UCSD AntiViral Research Center (AVRC)

    San Diego, California, 92103, United States

  • University Medical Center

    New Orleans, Louisiana, 70119, United States

  • University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)

    Chicago, Illinois, 60612, United States

  • University of South Florida - Curran Children's Health Center

    Tampa, Florida, 33606, United States

  • Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington

    Seattle, Washington, 98104, United States

  • Whitman-Walker Institute, Inc.

    Washington D.C., District of Columbia, 20009, United States

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut, 06510, United States

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