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NCT07645287PHASE2Recruiting

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

Gilead Sciences

Start Date

6/15/2026

Completion Date

4/1/2033

Summary

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

GS-3242 Tablet

DRUG

GS-3242 Injection

DRUG

Lenacapavir Tablet

DRUG

Lenacapavir Injection

DRUG

B/F/TAF

Interested in This Trial?

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Conditions

HIV-1-infection

Locations

Pueblo Family Physicians

Phoenix, Arizona 85015

United States

Pacific Oak Medical Group

Beverly Hills, California 90211

United States

Ruane Clinical Research Group Inc.

Los Angeles, California 90036

United States

Optimus Medical Group

San Francisco, California 94102

United States

University of California San Francisco, Community and Clinical Research Center

San Francisco, California 94110

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California 90502

United States

Vivent Health

Denver, Colorado 80246

United States

Midland Florida Clinical Research Center, LLC

DeLand, Florida 32720

United States

CAN Community Health Fort Lauderdale

Fort Lauderdale, Florida 33316

United States

Midway Immunology and Research Center

Ft. Pierce, Florida 34982

United States

AIDS Healthcare Foundation -Coconut Grove

Miami, Florida 33133

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida 33016

United States

Orlando Immunology Center, PA

Orlanda, Florida 32803

United States

AHF - Pensacola

Pensacola, Florida 32504

United States

CAN Community Health Inc.

Sarasota, Florida 34237

United States

Triple O Research Institute, PA

West Palm Beach, Florida 33407

United States

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia 30308

United States

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

Decatur, Georgia 30033

United States

Mercer University, Department of Internal Medicine

Macon, Georgia 31201

United States

Chatham County Health Department

Savannah, Georgia 31401

United States

Be Well Medical Center

Berkeley, Michigan 48072

United States

KC CARE Health Center

Kansas City, Missouri 64111

United States

Southampton Community Healthcare

St Louis, Missouri 63139

United States

ID care

Hillsborough, New Jersey 08844

United States

Saint Michael's Medical Center

Newark, New Jersey 07102

United States

South Jersey Infectious Disease

Somers Point, New Jersey 08244

United States

AXCES Research Group, LLC

Sante Fe, New Mexico 87505

United States

Brooklyn Clinical Research

Brooklyn, New York 11226

United States

NewYork-Presbyterian Queens

Flushing, New York 11355

United States

NYU Langone Health Vaccine Center

New York, New York 10016

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Rosedale Health and Wellness

Huntersville, North Carolina 28078

United States

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Philadelphia, Pennsylvania 19107

United States

Central Texas Clinical Research

Austin, Texas 78705

United States

St. Hope Foundation

Bellaire, Texas 77401

United States

Prism Health North Texas

Dallas, Texas 75208

United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas 75246

United States

AXCES Research Group, LLC

El Paso, Texas 79902

United States

Texas Centers for Infectious Disease Associates

Fort Worth, Texas 76109

United States

The Crofoot Research Center, INC.

Houston, Texas 77098

United States

Diagnostic Clinic of Longview

Longview, Texas 75605

United States

AXCES Research Group, LLC

Salt Lake City, Utah 84102

United States

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

Annandale, Virginia 22003

United States

TribalMed PLLC

Seattle, Washington 98104

United States

MultiCare-Deaconess Medical Office Building 2

Spokane, Washington 99202

United States

Taylor Square Private Clinic

Surry Hills, New South Wales 2010

Australia

Momentum Clinical Research Darlinghurst

Sydney, New South Wales 2010 NSW

Australia

East Sydney Doctors

Sydney, New South Wales 2010

Australia

Prahran Market Clinic,

South Yarra, Victoria 3141

Australia

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

CMU du Quartier Latin

Montreal, H2L 5B1

Canada

Spectrum Health

Vancouver, V6Z2T1

Canada

Proyecto ACTU

Rio Piedras, PR 00925

Puerto Rico

Clinical Research Puerto Rico

San Juan, PR 00909

Puerto Rico

HOPE Clinical Research

San Juan, PR 00909

Puerto Rico