Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

NCT06630286 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GS-US-563-59252024-514046-37
• Study Type: interventional
• Target: 609
• Locations: 12 countries
• Sites: 106

Brief Summary

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm

  Week 48

Secondary Outcomes (6)

• Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm

  Week 96

• Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 as Determined by the US FDA-Defined Snapshot Algorithm

  Week 48

• Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm

  Week 96

• Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48

  Week 48

• Change From Baseline in CD4 T-Cell Count at Weeks 96

  Week 96

Study Arms (3)

Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF

EXPERIMENTAL

Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive PTM B/F/TAF once daily from Day 1 up to Week 96.

Drug: ISL/LEN; Drug: PTM B/F/TAF

Blinded Phase: PTM ISL/LEN + B/F/TAF

EXPERIMENTAL

Participants will receive an initial dose of PTM ISL/LEN (Dose A), followed by once weekly PTM ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive B/F/TAF (50/200/25 mg) once daily up from Day 1 up to Week 96.

Drug: B/F/TAF; Drug: PTM ISL/LEN

Open- Label Extension (OLE) Phase

EXPERIMENTAL

After the end of Blinded Phase at Week 96, if safety and efficacy of ISL/LEN are demonstrated following review of unblinded data, all participants will be given an option to enter the open-label extension phase to receive ISL/LEN in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL/LEN and PTM B/F/TAF during the blinded phase will continue to take ISL/LEN weekly. Participants receiving B/F/TAF and PTM ISL/LEN during the blinded phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.

Drug: ISL/LEN

Interventions

ISL/LEN DRUG

Tablet administered orally

Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF; Open- Label Extension (OLE) Phase

B/F/TAF DRUG

Tablet administered orally

Also known as: Biktarvy®

Blinded Phase: PTM ISL/LEN + B/F/TAF

PTM B/F/TAF DRUG

Tablet administered orally

Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF

PTM ISL/LEN DRUG

Tablet administered orally

Blinded Phase: PTM ISL/LEN + B/F/TAF

Eligibility Criteria

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

You may qualify if:

• HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:
• One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
• Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
• During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 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.
• Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
• Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

You may not qualify if:

• Prior virologic failure.
• Prior use of, or exposure to ISL or LEN.
• Active, serious infections requiring parenteral therapy within 30 days before randomization.
• Active tuberculosis infection.
• Acute hepatitis within 30 days before randomization.
• Hepatitis B virus (HBV) infection as determined below at the screening visit:
• Positive HBV surface antigen OR
• Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody 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) may be enrolled.
• Any of the following laboratory values at screening:
• Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
• Alanine aminotransferase \> 5 x upper limit of normal (ULN)
• Direct bilirubin \> 1.5 x ULN
• Platelets \< 50,000/μL
• Hemoglobin \< 8.0 g/dL

Sponsors & Collaborators

• Gilead Sciences: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (106)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Pueblo Family Physicians

Phoenix, Arizona, 85015, United States

Location

Kaiser Permanente Southern California

Los Angeles, California, 90027, United States

Location

Ruane Clinical Research Group, Inc

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

BIOS Clinical Research

Palm Springs, California, 92262, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

Vivent Health

Denver, Colorado, 80246, United States

Location

University of Colorado- Anschutz Medical Campus - PPDS

Denver, Colorado, 80262, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Whitman-Walker Health

Washington D.C., District of Columbia, 20009, United States

Location

CAN Community Health

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

CAN Community Health

Miami Gardens, Florida, 33055, United States

Location

Midland Research Group, Inc.

Oakland Park, Florida, 33334, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

AHF (AIDS Healthcare Foundation) - Pensacola Research

Pensacola, Florida, 32504, United States

Location

CAN Community Health

Sarasota, Florida, 34237, United States

Location

St. Josephs Comprehensive Research Institute

Tampa, Florida, 33607, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Mercer University

Macon, Georgia, 31201, United States

Location

Chatham CARE Center

Savannah, Georgia, 31401, United States

Location

Howard Brown Health

Chicago, Illinois, 60613, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Community Research Initiative

Boston, Massachusetts, 02129, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Trinity Health

Grand Rapids, Michigan, 49503, United States

Location

KC CARE Health Center

Kansas City, Missouri, 64111, United States

Location

ID CARE

Hillsborough, New Jersey, 08844, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

AXCES Research Group - Albuquerque

Santa Fe, New Mexico, 87505, United States

Location

Brooklyn Clinical Research Center

Brooklyn, New York, 11226, United States

Location

New York Presbyterian Hospital

Flushing, New York, 11355, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

CTRC University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Atrium Health Infectious Disease Kenilworth

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Brody School of Medicine at East Carolina University Adult Specialty Care

Greenville, North Carolina, 27858, United States

Location

Rosedale Health and Wellness

Huntersville, North Carolina, 28078, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Prisma Health/USC

Columbia, South Carolina, 29203, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

AXCES Research Group, LLC

El Paso, Texas, 79902, United States

Location

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

The Crofoot Research Center, INC.

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

AXCES Research Group, LLC

Salt Lake City, Utah, 84102, United States

Location

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

Annandale, Virginia, 22003, United States

Location

Peter Shalit MD

Seattle, Washington, 98104, United States

Location

MultiCare Institute for Research & Innovation

Spokane, Washington, 99202, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Fundacion Huesped

Buenos Aires, 1202, Argentina

Location

Helios Salud S.A.

Buenos Aires, 1425, Argentina

Location

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Surry Hills, New South Wales, 2010, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Prahran Market Private Clinic

South Yarra, Victoria, 3141, Australia

Location

Clinique de médecine Urbaine du Quartier Latin

Montreal, H2L 0B1, Canada

Location

McGill University Health Centr

Montreal, H4A 3J1, Canada

Location

Spectrum Health

Vancouver, V6Z 2T1, Canada

Location

CHU Bordeaux - Hopital Saint André

Bourdeaux, 33075, France

Location

AP-HP-Hopital Bicétre

Le Kremlin-Bicêtre, 94270, France

Location

Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite

Marseile, 13009, France

Location

CHU Nice - Hopital Archet I

Nice, 6203, France

Location

EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

Berlin, 10787, Germany

Location

University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz

Bonn, 53127, Germany

Location

Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80

Cologne, 50924, Germany

Location

Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz

Essen, 45122, Germany

Location

ICH Study Center GmbH & Co.KG

Hamburg, 20146, Germany

Location

Chiba University Hospital

Chiba, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

University of the Ryukyus Hospital

Okinawa, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka Fu, 540-0006, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Japan Institute for Health Security National Center for Global Health and Medicine

Tokyo, 162-8655,, Japan

Location

Clinical Research Puerto Rico

San Juan, PR, 00909, Puerto Rico

Location

University of Puerto Rico School of Medicine

San Juan, PR, 00935, Puerto Rico

Location

Complexo Hospitalario Universitario da Coruna

A Coruña, 15006, Spain

Location

Hospital Universitario Vall d' Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Regional de Malaga

Málaga, 29010, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

Kaohsuing Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsuing Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 22060, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taoyuan General Hospital

Taoyuan City, 33004, Taiwan

Location

Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)

Birmingham, B9 5SS, United Kingdom

Location

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

Brighton, BN2 3EW, United Kingdom

Location

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

London, E1 1BB., United Kingdom

Location

Royal Free Hospital (Royal Free London NHS Foundation Trust)

London, NW3 2QG, United Kingdom

Location

Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)

London, SW10 9TH, United Kingdom

Location

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

London, WC1E 6JB, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: October 9, 2024
• Primary Completion: April 17, 2026
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); ES (4); CH (3); DE (5); TW (5); JP (7); FR (4); US (60); AR (2); GB (6); PR (2); AU (5)