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Could a shot every 6 months replace daily HIV pills?

NCT ID NCT05729568

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a combination of two lab-made antibodies and an antiviral drug called lenacapavir, given every 6 months, can keep HIV under control in adults whose virus is already suppressed by daily pills. About 83 participants will either switch to the new long-acting regimen or stay on their current oral therapy. The main goal is to see if the new treatment is as effective at keeping HIV levels low after 26 weeks.

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

83 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2030

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 to 65 years

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: * On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. * No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q). * Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL at screening visit 2. * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable. * Proviral phenotypic sensitivity to both teropavimab and zinlirvimab by the PhenoSense Assay (Monogram Biosciences). * Screening clusters of differentiation 4 (CD4)+ T-cell count ≥ 200 cells/μL at screening visit 2. Key Exclusion Criteria: * Comorbid condition requiring ongoing immunosuppression. * Hepatitis C virus (HCV) antibody positive and HCV RNA detectable. * Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2. * History of opportunistic infection or illness indicative of Stage 3 HIV disease. 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

Contacts and locations

Locations

  • AIDS Arms, Inc. DBA Prism Health North Texas

    Dallas, Texas, 75208, United States

  • AXCES Research Group, LLC

    Albuquerque, New Mexico, 87109, United States

  • AXCES Research Group, LLC

    El Paso, Texas, 79902, United States

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Can Community Health Care

    Fort Lauderdale, Florida, 33316, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

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

    Annandale, Virginia, 22003, United States

  • Clinical Research Puerto Rico

    San Juan, 909, Puerto Rico

  • Duke University Health Center

    Durham, North Carolina, 27710, United States

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010, Australia

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010 NSW, Australia

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033, United States

  • Maple Leaf Research/Maple Leaf Medical Clinic

    Toronto, M5G 1K2, Canada

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

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

    Chapel Hill, North Carolina, 27514, United States

  • Optimus Medical Group

    San Francisco, California, 94102, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Prisma Health - Clinical Research Unit

    Columbia, South Carolina, 29203, United States

  • Regional Center for Infectious Disease Research

    Greensboro, North Carolina, 27401, United States

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078, United States

  • Ruane Clinical Research Group, Inc.

    Los Angeles, California, 90036, United States

  • Southhampton Healthcare, Inc

    St Louis, Missouri, 63139, United States

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27858, United States

  • The Crofoot Research Center, INC

    Houston, Texas, 77098, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • UC San Diego (UCSD) AntiViral Research Center (AVRC)

    San Diego, California, 92103, United States

  • University of Colorado Clinical and Translational Research Center

    Aurora, Colorado, 80045, United States

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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