A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Last updated: January 9, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hiv Infections

Treatment

Lenacapavir Injection

Lenacapavir Tablet

Teropavimab

Clinical Study ID

NCT05729568
GS-US-536-5939
  • Ages 18-65
  • All Genders

Study Summary

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.

The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, teropavimab, and zinlirvimab, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • On stable oral antiretroviral therapy (ART) consisting of no more than 2 drugclasses (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 toscreening 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 ARTregimen with the exception of isolated nucleoside reverse transcriptase inhibitormutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R,L210W, T215Y, and/or K219Q).

  • Plasma HIV-1 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 thelimit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.

  • Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening orfrom protocol GS-US-536-5816 within 24 months prior to screening.

  • Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2.

Exclusion

Key Exclusion Criteria:

  • Comorbid condition requiring ongoing immunosuppression.

  • Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneouslyor with treatment is acceptable)

  • Evidence of current hepatitis B virus (HBV) infection regardless of HBV surfaceantigen 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.

Study Design

Total Participants: 83
Treatment Group(s): 5
Primary Treatment: Lenacapavir Injection
Phase: 2
Study Start date:
May 15, 2023
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • East Sydney Doctors

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Holdsworth House Medical Practice

    Sydney, New South Wales 2010 NSW
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • CMU Quartier Latin Inc

    Montreal, H2L 0B1
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • Maple Leaf Research/Maple Leaf Medical Clinic

    Toronto, M5G 1K2
    Canada

    Site Not Available

  • University Health Network - Toronto General Hospital

    Toronto, M5G 2N2
    Canada

    Active - Recruiting

  • Clinical Research Puerto Rico

    San Juan, 909
    Puerto Rico

    Site Not Available

  • Be Well Medical Center

    Berkeley, California 48072
    United States

    Site Not Available

  • Mills Clinical Research

    Los Angeles, California 90069
    United States

    Site Not Available

  • Ruane Clinical Research Group, Inc.

    Los Angeles, California 90036
    United States

    Site Not Available

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

    San Diego, California 92103
    United States

    Site Not Available

  • Optimus Medical Group

    San Francisco, California 94102
    United States

    Site Not Available

  • University of Colorado Clinical and Translational Research Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida 32720
    United States

    Site Not Available

  • Can Community Health Care

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Midway Immunology and Research Center

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Orlando Immunology Center

    Orlando, Florida 32803
    United States

    Site Not Available

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Be Well Medical Center

    Berkley, Michigan 48072
    United States

    Site Not Available

  • Southhampton Healthcare, Inc

    Saint Louis, Missouri 63139
    United States

    Site Not Available

  • ID Care, P.A.

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • AXCES Research Group, LLC

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

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

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University Health Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Regional Center for Infectious Disease Research

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • The Brody School of Medicine at East Carolina University

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • Rosedale Health and Wellness

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Prisma Health - Clinical Research Unit

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • St Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Central Texas Clinical Research

    Austin, Texas 78705
    United States

    Site Not Available

  • AIDS Arms, Inc. DBA Prism Health North Texas

    Dallas, Texas 75208
    United States

    Site Not Available

  • North Texas Infectious Diseases Consultant's, P.A.

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • AXCES Research Group, LLC

    El Paso, Texas 79902
    United States

    Site Not Available

  • The Crofoot Research Center, INC

    Houston, Texas 77098
    United States

    Site Not Available

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

    Annandale, Virginia 22003
    United States

    Site Not Available

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