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Could a shot replace daily HIV pills? new trial tests Two-Injection combo

NCT ID NCT07645287

Disease control 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This Phase 2 trial tests whether switching to a combination of two injectable drugs, GS-3242 and lenacapavir, works as well as staying on the daily pill Biktarvy for people with HIV who already have the virus under control. About 175 participants will be randomly assigned to either the injectable regimen or continue their current pill. The main goal is to see if the injectable keeps the virus suppressed at 35 weeks (Part A) and 26 weeks (Part B).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GS-3242 and lenacapavir (injectable drugs)
What this could lead to
If successful, this could offer people with HIV a long-acting injectable alternative to daily pills, making treatment easier and more private.
What could go wrong
This is an early Phase 2 trial with only 175 participants. The injectable regimen may not keep the virus suppressed as well as the daily pill, and side effects from the injections are possible.

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

About 175 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2033

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening. * No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S). Key Exclusion Criteria: * Prior use of, or exposure to GS-3242 or LEN. * History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen. * Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV-1-infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHF - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

  • AIDS Healthcare Foundation -Coconut Grove

    RECRUITING

    Miami, Florida, 33133, United States

  • AXCES Research Group, LLC

    RECRUITING

    Sante Fe, New Mexico, 87505, United States

  • AXCES Research Group, LLC

    RECRUITING

    El Paso, Texas, 79902, United States

  • AXCES Research Group, LLC

    RECRUITING

    Salt Lake City, Utah, 84102, United States

  • Be Well Medical Center

    RECRUITING

    Berkeley, Michigan, 48072, United States

  • Brooklyn Clinical Research

    RECRUITING

    Brooklyn, New York, 11226, United States

  • CAN Community Health Fort Lauderdale

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • CAN Community Health Inc.

    RECRUITING

    Sarasota, Florida, 34237, United States

  • CMU du Quartier Latin

    RECRUITING

    Montreal, H2L 5B1, Canada

  • Central Texas Clinical Research

    RECRUITING

    Austin, Texas, 78705, United States

  • Chatham County Health Department

    RECRUITING

    Savannah, Georgia, 31401, United States

  • Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID

    RECRUITING

    Annandale, Virginia, 22003, United States

  • Clinical Research Puerto Rico

    RECRUITING

    San Juan, PR, 00909, Puerto Rico

  • Diagnostic Clinic of Longview

    RECRUITING

    Longview, Texas, 75605, United States

  • East Sydney Doctors

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • Emory University Hospital Midtown Infectious Disease Clinic

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Floridian Clinical Research, LLC

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • HOPE Clinical Research

    RECRUITING

    San Juan, PR, 00909, Puerto Rico

  • ID care

    RECRUITING

    Hillsborough, New Jersey, 08844, United States

  • KC CARE Health Center

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Mercer University, Department of Internal Medicine

    RECRUITING

    Macon, Georgia, 31201, United States

  • Metro Infectious Disease Consultants, P.L.L.C.

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Midland Florida Clinical Research Center, LLC

    RECRUITING

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center

    RECRUITING

    Ft. Pierce, Florida, 34982, United States

  • Momentum Clinical Research Darlinghurst

    RECRUITING

    Sydney, New South Wales, 2010 NSW, Australia

  • Montefiore Medical Center

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10467, United States

  • MultiCare-Deaconess Medical Office Building 2

    ACTIVE_NOT_RECRUITING

    Spokane, Washington, 99202, United States

  • NYU Langone Health Vaccine Center

    RECRUITING

    New York, New York, 10016, United States

  • NewYork-Presbyterian Queens

    RECRUITING

    Flushing, New York, 11355, United States

  • North Texas Infectious Disease Consultants, P.A.

    RECRUITING

    Dallas, Texas, 75246, United States

  • Optimus Medical Group

    RECRUITING

    San Francisco, California, 94102, United States

  • Orlando Immunology Center, PA

    RECRUITING

    Orlanda, Florida, 32803, United States

  • Pacific Oak Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Prahran Market Clinic,

    RECRUITING

    South Yarra, Victoria, 3141, Australia

  • Prism Health North Texas

    RECRUITING

    Dallas, Texas, 75208, United States

  • Proyecto ACTU

    RECRUITING

    Rio Piedras, PR, 00925, Puerto Rico

  • Pueblo Family Physicians

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85015, United States

  • Rosedale Health and Wellness

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Ruane Clinical Research Group Inc.

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    RECRUITING

    Newark, New Jersey, 07102, United States

  • South Jersey Infectious Disease

    RECRUITING

    Somers Point, New Jersey, 08244, United States

  • Southampton Community Healthcare

    RECRUITING

    St Louis, Missouri, 63139, United States

  • Spectrum Health

    ACTIVE_NOT_RECRUITING

    Vancouver, V6Z2T1, Canada

  • St. Hope Foundation

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Taylor Square Private Clinic

    RECRUITING

    Surry Hills, New South Wales, 2010, Australia

  • Texas Centers for Infectious Disease Associates

    ACTIVE_NOT_RECRUITING

    Fort Worth, Texas, 76109, United States

  • The Crofoot Research Center, INC.

    RECRUITING

    Houston, Texas, 77098, United States

  • TribalMed PLLC

    RECRUITING

    Seattle, Washington, 98104, United States

  • Triple O Research Institute, PA

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • University of California San Francisco, Community and Clinical Research Center

    RECRUITING

    San Francisco, California, 94110, United States

  • Vivent Health

    RECRUITING

    Denver, Colorado, 80246, United States

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