Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
NCT ID: NCT06630286
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
609 participants
INTERVENTIONAL
2024-10-09
2030-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF
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.
ISL/LEN
Tablet administered orally
PTM B/F/TAF
Tablet administered orally
Blinded Phase: PTM ISL/LEN + B/F/TAF
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.
B/F/TAF
Tablet administered orally
PTM ISL/LEN
Tablet administered orally
Open- Label Extension (OLE) Phase
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.
ISL/LEN
Tablet administered orally
Interventions
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ISL/LEN
Tablet administered orally
B/F/TAF
Tablet administered orally
PTM B/F/TAF
Tablet administered orally
PTM ISL/LEN
Tablet administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
3. 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.
Exclusion Criteria
* 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:
1. Positive HBV surface antigen OR
2. 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:
1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
2. Alanine aminotransferase \> 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Kaiser Permanente Southern California
Los Angeles, California, United States
Ruane Clinical Research Group, Inc
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
BIOS Clinical Research
Palm Springs, California, United States
Optimus Medical Group
San Francisco, California, United States
Vivent Health
Denver, Colorado, United States
University of Colorado- Anschutz Medical Campus - PPDS
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
CAN Community Health
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
CAN Community Health
Miami Gardens, Florida, United States
Midland Research Group, Inc.
Oakland Park, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AHF (AIDS Healthcare Foundation) - Pensacola Research
Pensacola, Florida, United States
CAN Community Health
Sarasota, Florida, United States
St. Josephs Comprehensive Research Institute
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University
Macon, Georgia, United States
Chatham CARE Center
Savannah, Georgia, United States
Howard Brown Health
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Community Research Initiative
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Trinity Health
Grand Rapids, Michigan, United States
KC CARE Health Center
Kansas City, Missouri, United States
ID CARE
Hillsborough, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
AXCES Research Group - Albuquerque
Santa Fe, New Mexico, United States
Brooklyn Clinical Research Center
Brooklyn, New York, United States
New York Presbyterian Hospital
Flushing, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Infectious Disease Kenilworth
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Brody School of Medicine at East Carolina University Adult Specialty Care
Greenville, North Carolina, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Prisma Health/USC
Columbia, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
AXCES Research Group, LLC
El Paso, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
AXCES Research Group, LLC
Salt Lake City, Utah, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
Peter Shalit MD
Seattle, Washington, United States
MultiCare Institute for Research & Innovation
Spokane, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Fundacion Huesped
Buenos Aires, , Argentina
Helios Salud S.A.
Buenos Aires, , Argentina
East Sydney Doctors
Darlinghurst, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Prahran Market Private Clinic
South Yarra, Victoria, Australia
Clinique de médecine Urbaine du Quartier Latin
Montreal, , Canada
McGill University Health Centr
Montreal, , Canada
Spectrum Health
Vancouver, , Canada
CHU Bordeaux - Hopital Saint André
Bourdeaux, , France
AP-HP-Hopital Bicétre
Le Kremlin-Bicêtre, , France
Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite
Marseile, , France
CHU Nice - Hopital Archet I
Nice, , France
EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin
Berlin, , Germany
University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz
Bonn, , Germany
Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80
Cologne, , Germany
Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz
Essen, , Germany
ICH Study Center GmbH & Co.KG
Hamburg, , Germany
Chiba University Hospital
Chiba, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
University of the Ryukyus Hospital
Okinawa, , Japan
Osaka City General Hospital
Osaka, , Japan
National Hospital Organization Osaka National Hospital
Osaka Fu, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Japan Institute for Health Security National Center for Global Health and Medicine
Tokyo, , Japan
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico
University of Puerto Rico School of Medicine
San Juan, PR, Puerto Rico
Complexo Hospitalario Universitario da Coruna
A Coruña, , Spain
Hospital Universitario Vall d' Hebron
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitario Regional de Malaga
Málaga, , Spain
Inselspital
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Kaohsuing Medical University Hospital
Kaohsiung City, , Taiwan
Kaohsuing Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taoyuan General Hospital
Taoyuan, , Taiwan
Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)
Birmingham, , United Kingdom
Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)
Brighton, , United Kingdom
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)
London, , United Kingdom
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, , United Kingdom
Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)
London, , United Kingdom
Mortimer Market Centre (Central and North West London NHS Foundation Trust)
London, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2024-514046-37
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-563-5925
Identifier Type: -
Identifier Source: org_study_id