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

NCT07645287 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GS-US-643-7710
• Study Type: interventional
• Target: 175
• Locations: 4 countries
• Sites: 55

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Week 26

Secondary Outcomes (14)

• Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

  Week 52

• Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm

  Week 35

• Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

  Week 52

• Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35

  Baseline, Week 35

• Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52

  Baseline, Week 52

Study Arms (4)

Part A: Group 1 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Part A: Group 2 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Part A: Group 3 of B/F/TAF

EXPERIMENTAL

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

Drug: B/F/TAF

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

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Interventions

GS-3242 Injection DRUG

Administered intramuscularly (IM)

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Lenacapavir Tablet DRUG

Administered orally

Also known as: LEN

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Lenacapavir Injection DRUG

Administered IM

Also known as: LEN

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

B/F/TAF DRUG

Administered orally

Part A: Group 3 of B/F/TAF

GS-3242 Tablet DRUG

Administered orally

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (55)

Pueblo Family Physicians

Phoenix, Arizona, 85015, United States

ACTIVE NOT RECRUITING

Pacific Oak Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Ruane Clinical Research Group Inc.

Los Angeles, California, 90036, United States

ACTIVE NOT RECRUITING

Optimus Medical Group

San Francisco, California, 94102, United States

RECRUITING

University of California San Francisco, Community and Clinical Research Center

San Francisco, California, 94110, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

Vivent Health

Denver, Colorado, 80246, United States

RECRUITING

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

RECRUITING

CAN Community Health Fort Lauderdale

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

RECRUITING

AIDS Healthcare Foundation -Coconut Grove

Miami, Florida, 33133, United States

RECRUITING

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

RECRUITING

Orlando Immunology Center, PA

Orlanda, Florida, 32803, United States

RECRUITING

AHF - Pensacola

Pensacola, Florida, 32504, United States

RECRUITING

CAN Community Health Inc.

Sarasota, Florida, 34237, United States

RECRUITING

Triple O Research Institute, PA

West Palm Beach, Florida, 33407, United States

RECRUITING

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, 30308, United States

RECRUITING

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

Decatur, Georgia, 30033, United States

RECRUITING

Mercer University, Department of Internal Medicine

Macon, Georgia, 31201, United States

RECRUITING

Chatham County Health Department

Savannah, Georgia, 31401, United States

RECRUITING

Be Well Medical Center

Berkeley, Michigan, 48072, United States

RECRUITING

KC CARE Health Center

Kansas City, Missouri, 64111, United States

RECRUITING

Southampton Community Healthcare

St Louis, Missouri, 63139, United States

RECRUITING

ID care

Hillsborough, New Jersey, 08844, United States

RECRUITING

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

RECRUITING

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

RECRUITING

AXCES Research Group, LLC

Sante Fe, New Mexico, 87505, United States

RECRUITING

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

RECRUITING

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

RECRUITING

NYU Langone Health Vaccine Center

New York, New York, 10016, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

ACTIVE NOT RECRUITING

Rosedale Health and Wellness

Huntersville, North Carolina, 28078, United States

RECRUITING

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Central Texas Clinical Research

Austin, Texas, 78705, United States

RECRUITING

St. Hope Foundation

Bellaire, Texas, 77401, United States

RECRUITING

Prism Health North Texas

Dallas, Texas, 75208, United States

RECRUITING

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas, 75246, United States

RECRUITING

AXCES Research Group, LLC

El Paso, Texas, 79902, United States

RECRUITING

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, 76109, United States

ACTIVE NOT RECRUITING

The Crofoot Research Center, INC.

Houston, Texas, 77098, United States

RECRUITING

Diagnostic Clinic of Longview

Longview, Texas, 75605, United States

RECRUITING

AXCES Research Group, LLC

Salt Lake City, Utah, 84102, United States

RECRUITING

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

Annandale, Virginia, 22003, United States

RECRUITING

TribalMed PLLC

Seattle, Washington, 98104, United States

RECRUITING

MultiCare-Deaconess Medical Office Building 2

Spokane, Washington, 99202, United States

ACTIVE NOT RECRUITING

Taylor Square Private Clinic

Surry Hills, New South Wales, 2010, Australia

RECRUITING

Momentum Clinical Research Darlinghurst

Sydney, New South Wales, 2010 NSW, Australia

RECRUITING

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

RECRUITING

Prahran Market Clinic,

South Yarra, Victoria, 3141, Australia

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

CMU du Quartier Latin

Montreal, H2L 5B1, Canada

RECRUITING

Spectrum Health

Vancouver, V6Z2T1, Canada

ACTIVE NOT RECRUITING

Proyecto ACTU

Rio Piedras, PR, 00925, Puerto Rico

RECRUITING

Clinical Research Puerto Rico

San Juan, PR, 00909, Puerto Rico

RECRUITING

HOPE Clinical Research

San Juan, PR, 00909, Puerto Rico

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment (Part A randomized parallel groups; Part B (conditional) single-arm, non-randomized)

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): April 1, 2033
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (45); CA (3); PR (3); AU (4)