Recruiting
Phase 2

GS-3242 & LEN

Sponsor:

Gilead Sciences

Code:

NCT07645287

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GS-3242 Tablet

GS-3242 Injection

Lenacapavir Tablet

Lenacapavir Injection

B/F/TAF

Study Details

Brief 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.

Conditions

HIV-1-infection

Study ID

NCT07645287

Start date

Jun 15, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2033

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Group 1 of GS-3242 + LEN

Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.

experimental: Part A: Group 2 of GS-3242 + LEN

Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.

experimental: Part A: Group 3 of B/F/TAF

Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.

experimental: Part B: Group 4 (Conditional) of GS-3242 + LEN

Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.

Interventions

GS-3242 Tablet

Administered orally

GS-3242 Injection

Administered intramuscularly (IM)

Lenacapavir Tablet

Administered orally

Lenacapavir Injection

Administered IM

B/F/TAF

Administered orally

Primary outcome measure

  • Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm [ Time Frame: Week 35 ]
  • Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Pacific Oak Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Optimus Medical Group

Recruiting

San Francisco, California, United States, 94102

University of California San Francisco, Community and Clinical Research Center

Recruiting

San Francisco, California, United States, 94110

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Vivent Health

Recruiting

Denver, Colorado, United States, 80246

Midland Florida Clinical Research Center, LLC

Recruiting

DeLand, Florida, United States, 32720

CAN Community Health Fort Lauderdale

Recruiting

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Recruiting

Ft. Pierce, Florida, United States, 34982

AIDS Healthcare Foundation -Coconut Grove

Recruiting

Miami, Florida, United States, 33133

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016

Orlando Immunology Center, PA

Recruiting

Orlanda, Florida, United States, 32803

AHF - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

CAN Community Health Inc.

Recruiting

Sarasota, Florida, United States, 34237

Triple O Research Institute, PA

Recruiting

West Palm Beach, Florida, United States, 33407

Emory University Hospital Midtown Infectious Disease Clinic

Recruiting

Atlanta, Georgia, United States, 30308

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

Recruiting

Decatur, Georgia, United States, 30033

Mercer University, Department of Internal Medicine

Recruiting

Macon, Georgia, United States, 31201

Chatham County Health Department

Recruiting

Savannah, Georgia, United States, 31401

Be Well Medical Center

Recruiting

Berkeley, Michigan, United States, 48072

KC CARE Health Center

Recruiting

Kansas City, Missouri, United States, 64111

Southampton Community Healthcare

Recruiting

St Louis, Missouri, United States, 63139

ID care

Recruiting

Hillsborough, New Jersey, United States, 08844

Saint Michael's Medical Center

Recruiting

Newark, New Jersey, United States, 07102

South Jersey Infectious Disease

Recruiting

Somers Point, New Jersey, United States, 08244

AXCES Research Group, LLC

Recruiting

Sante Fe, New Mexico, United States, 87505

Brooklyn Clinical Research

Recruiting

Brooklyn, New York, United States, 11226

NewYork-Presbyterian Queens

Recruiting

Flushing, New York, United States, 11355

NYU Langone Health Vaccine Center

Recruiting

New York, New York, United States, 10016

Rosedale Health and Wellness

Recruiting

Huntersville, North Carolina, United States, 28078

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Central Texas Clinical Research

Recruiting

Austin, Texas, United States, 78705

St. Hope Foundation

Recruiting

Bellaire, Texas, United States, 77401

Prism Health North Texas

Recruiting

Dallas, Texas, United States, 75208

North Texas Infectious Disease Consultants, P.A.

Recruiting

Dallas, Texas, United States, 75246

AXCES Research Group, LLC

Recruiting

El Paso, Texas, United States, 79902

The Crofoot Research Center, INC.

Recruiting

Houston, Texas, United States, 77098

Diagnostic Clinic of Longview

Recruiting

Longview, Texas, United States, 75605

AXCES Research Group, LLC

Recruiting

Salt Lake City, Utah, United States, 84102

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

Recruiting

Annandale, Virginia, United States, 22003

TribalMed PLLC

Recruiting

Seattle, Washington, United States, 98104

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

CMU du Quartier Latin

Recruiting

Montreal, Canada, H2L 5B1

More Information

Sponsor

Gilead Sciences

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-09-04.