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Twice-Yearly HIV shots could replace daily pills

NCT ID NCT07682961

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether a combination of two antibodies (teropavimab and zinlirvimab) plus the drug lenacapavir, given as injections twice a year, can keep HIV under control in adults whose virus is already well-suppressed by daily oral medication. The study compares this approach to standard injections of cabotegravir and rilpivirine given every 8 weeks. The main goal is to see if the twice-yearly regimen is as effective at maintaining undetectable HIV levels after one year.

What this could mean

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

Active substance
lenacapavir, teropavimab, and zinlirvimab
What this could lead to
If successful, this could offer people with HIV a twice-yearly injection option, reducing the need for frequent shots or daily pills.
What could go wrong
This is a phase 3 trial, but the new combination may not be as effective as current treatments, and some participants may experience side effects or viral rebound.

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

About 590 people

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

Started

Jul 2026

Expected to finish

Mar 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: * Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria: 1\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening. * At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and \< 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \< 50 copies/mL. * A plasma HIV-1 RNA test \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening. 1\) If \> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). * On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening. 1. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be \< 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1. Key Exclusion Criteria: * History of an opportunistic infection or illness indicative of Stage 3 HIV disease. * History of treatment failure. * Known or suspected resistance to either CAB or RPV. 1. Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H. 2. Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N. * Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV. * Known hypersensitivity to the study intervention, its metabolites, or formulation excipients. * Active, serious infections (other than HIV-1) requiring therapy \< 30 days prior to randomization. * Active tuberculosis infection. * Acute hepatitis of any cause \< 30 days before randomization. * History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C). * Active malignancy requiring acute systemic therapy. * Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs. * Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1. * Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV. * Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc. * Baseline regimen consisting of monotherapy with any single antiretroviral (ARV). * Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study. * Hepatitis C virus (HCV) antibody positive and HCV RNA detectable. * Chronic hepatitis B virus (HBV) infection, as determined by either: 1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. 2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit. * Severe renal impairment-estimated glomerular filtration rate \< 30 mL/min according to the Cockcroft-Gault formula. * Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator. * Any of the following laboratory values at screening: 1. Alanine aminotransferase \> 5 x upper limit of normal (ULN). 2. Direct bilirubin \> 1.5 x ULN. 3. Platelets \< 50,000/mm\^3. 4. Hemoglobin \< 8.0 g/dL. 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 infections

How to take part

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

  1. The places running it

    19 sites in 3 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

  • Atlanta ID Group, PC

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Atlantic Clinical Research Institute

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • BLISS Health Inc.

    RECRUITING

    Orlando, Florida, 32803, United States

  • Be Well Medical Center

    RECRUITING

    Berkley, Michigan, 48072, United States

  • CAN Community Health Fort Lauderdale

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • CAN Community Health Miami Gardens

    RECRUITING

    Miami Gardens, Florida, 33055, 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

  • East Sydney Doctors

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • KC CARE Health Center

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • MOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research

    RECRUITING

    Tampa, Florida, 33614, 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

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, 540-0006, Japan

  • North Texas Infectious Diseases Consultants, P.A.

    RECRUITING

    Dallas, Texas, 75246, United States

  • Optimus Medical Group

    RECRUITING

    San Francisco, California, 94102, United States

  • Taylor Square Private Clinic

    RECRUITING

    Surry Hills, New South Wales, 2010, Australia

  • TribalMed PLLC

    RECRUITING

    Seattle, Washington, 98104, United States

  • Triple O Research Institute, P.A.

    RECRUITING

    West Palm Beach, Florida, 33407, United States

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