Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

Last updated: March 19, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Antiretroviral Combinations

ISL/LEN

Clinical Study ID

NCT06630299
GS-US-563-5926
2024-514047-28
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).

The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
  1. One HIV-1 RNA < 50 copies/mL immediately preceding the 24 weeks period prior toscreening.

  2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, alllevels must be < 50 copies/mL.

  3. During the 6 to 12 months period prior to screening, transient detectableviremia ≥ 50 copies/mL is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits.

  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.

  • Are receiving guideline-recommended standard of care treatment such as InternationalAntiviral Society (IAS), Department of Health and Human Services (DHHS), EuropeanAIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior toscreening and willing to continue until Day 1. Individuals in Treatment Group 2 mustalso be willing to continue their standard of care through at least Week 96.

  • Individuals assigned female at birth and of childbearing potential who engage inheterosexual intercourse must agree to use protocol-specified methods ofcontraception.

Exclusion

Key Exclusion Criteria:

  • Prior virologic failure.

  • Prior use of, or exposure to, ISL or LEN.

  • Active, serious infections requiring parenteral therapy within 30 days beforerandomization.

  • Active tuberculosis infection.

  • Acute hepatitis within 30 days before randomization.

  • Hepatitis B virus (HBV) infection, as determined below at the screening visit:

  1. positive HBV surface antigen OR

  2. positive HBV core antibody and negative HBV surface antibody. Note: individualsfound to be susceptible to HBV infection (eg negative hepatitis B surfaceantibody at the screening visit, regardless of prior HBV vaccination history)should be recommended to receive HBV vaccination.

  • Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note:individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) maybe enrolled.

  • Any of the following laboratory values at screening:

  1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gaultformula

  2. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)

  3. Direct bilirubin > 1.5 x ULN

  4. Platelets < 50,000/μL

  5. Hemoglobin < 8.0 g/dL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Antiretroviral Combinations
Phase: 3
Study Start date:
October 08, 2024
Estimated Completion Date:
August 31, 2030

Connect with a study center

  • Fundacion Huesped

    Buenos Aires, 1202
    Argentina

    Active - Recruiting

  • East Sydney Doctors

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • St Vincent's Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales 2011
    Australia

    Active - Recruiting

  • Taylor Square Private Clinic

    Surry Hills, New South Wales 2010
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Prahran Market Clinic

    South Yarra, Victoria 3141
    Australia

    Active - Recruiting

  • University Hospital Hannover, Department for Rheumatology and Immunology

    Hannover, 30625
    Germany

    Active - Recruiting

  • Dr. Scholten & Schneeweiß GbR

    Köln, 50674
    Germany

    Active - Recruiting

  • Mannheimer Onkologie Praxis

    Mannheim, 68167
    Germany

    Active - Recruiting

  • MVZ München am Goetheplatz, MUC Research GmbH

    Munchen, 80337
    Germany

    Active - Recruiting

  • Chiba University Hospital

    Chiba,
    Japan

    Active - Recruiting

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital

    Okinawa,
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka Fu, 540-0006
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka-City, 534-0021
    Japan

    Active - Recruiting

  • National Center for Global Health and Medicine

    Tokyo, 162-8655,
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Active - Recruiting

  • Amsterdam UMC, Iocation AMC

    Amsterdam, 1105 az
    Netherlands

    Active - Recruiting

  • HOPE Clinical Research

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Maternal Infant Studies Center(CEMI)

    San Juan, 00936-5067
    Puerto Rico

    Active - Recruiting

  • Perinatal HIV Research Unit

    Soweto, 2013
    South Africa

    Active - Recruiting

  • Hospital Germans Trias I Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Inselspital, Freiburgstrasse 20. Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Hopitaux Universitaires de Geneve

    Geneva, 1205
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011
    Switzerland

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  • Kaohsiung Medical University Hospital

    Kaohsiung, 80756
    Taiwan

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  • Far Eastern Memorial Hospital

    New Taipei City, 22060
    Taiwan

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  • National Taiwan University Hospital

    Taipei City, 10002
    Taiwan

    Active - Recruiting

  • Taoyuan General Hospital

    Taoyuan City, 33004
    Taiwan

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  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research

    Bangkok, 10330
    Thailand

    Active - Recruiting

  • Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

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  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000
    Thailand

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  • Institute of HIV Research and Innovation (IHRI)

    Pathumwan, 10330
    Thailand

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  • Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 3EW
    United Kingdom

    Active - Recruiting

  • Caldecot Centre, King's College Hospital (King's College Hospital NHS Foundation Trust)

    London, SE5 9RJ
    United Kingdom

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  • Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)

    London, E1 1BB.
    United Kingdom

    Active - Recruiting

  • Mortimer Market Centre (Central and North West London NHS Foundation Trust)

    London, WC1E 6JB
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital (Royal Free London NHS Foundation Trust)

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham(UAB) 1917 Research Clinic

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Pueblo Family Physicians

    Phoenix, Arizona 85015
    United States

    Active - Recruiting

  • Ruane Clinical Research Group

    Los Angeles, California 90036
    United States

    Active - Recruiting

  • Vv-Tmf-5366229

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • BIOS Clinical Research

    Palm Springs, California 92262
    United States

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  • University of Colorado Clinical and Translational Research Center

    Denver, Colorado 80262
    United States

    Active - Recruiting

  • Vivent Health

    Denver, Colorado 80246
    United States

    Active - Recruiting

  • Yale University; School of Medicine; AIDS Program

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Aids Healthcare Foundation - Northpoint

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Midway Immunology and Research Center

    Fort Pierce, Florida 34982
    United States

    Active - Recruiting

  • CAN Community Health

    Miami Gardens, Florida 33055
    United States

    Active - Recruiting

  • Orlando Immunology Center

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • AHF Pensacola

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • CAN Community Health

    Sarasota, Florida 34237
    United States

    Active - Recruiting

  • BayCare Health System, Inc./St. Joseph's Hospital

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

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

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Mercer University, Department of Internal Medicine

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Chatham County Health Department

    Savannah, Georgia 31401
    United States

    Active - Recruiting

  • Howard Brown Health Center

    Chicago, Illinois 60613
    United States

    Active - Recruiting

  • Indiana CTSI Clinical Research Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Brigham and Womens's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)

    Boston, Massachusetts 02129
    United States

    Active - Recruiting

  • Be Well Medical Center

    Berkley, Michigan 48072
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • ID Care

    Hillsborough, New Jersey 08844
    United States

    Active - Recruiting

  • Saint Michael's Medical Center

    Newark, New Jersey 07102
    United States

    Active - Recruiting

  • AXCES Research Group, LLC

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • Jacobi Medical Center

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • NewYork-Presbyterian Queens

    Flushing, New York 11355
    United States

    Active - Recruiting

  • Duke University Health System(DUHS)

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • ECU Health Leo Jenkins Cancer Building

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Rosedale Health and Wellness

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Prisma Health Midlands - Clinical Research Unit

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Central Texas Clinical Research

    Austin, Texas 78705
    United States

    Active - Recruiting

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • AXCES Research Group, LLC

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • The Crofoot Research Center, INC.

    Houston, Texas 77098
    United States

    Active - Recruiting

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

    Longview, Texas 75605
    United States

    Active - Recruiting

  • AXCES Research Group, LLC

    Salt Lake City, Utah 84102
    United States

    Active - Recruiting

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

    Annandale, Virginia 22003
    United States

    Active - Recruiting

  • MultiCare Rockwood Main Clinic

    Spokane, Washington 99202
    United States

    Active - Recruiting

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