Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
- Conditions
- HIV-1-infection
- Interventions
- Drug: ISL/LENDrug: B/F/TAFDrug: PTM B/F/TAFDrug: PTM ISL/LEN
- Registration Number
- NCT06630286
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-
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.
Key
-
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF ISL/LEN 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. Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF 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. Blinded Phase: PTM ISL/LEN + B/F/TAF 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. Blinded Phase: PTM ISL/LEN + B/F/TAF PTM ISL/LEN 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. Open- Label Extension (OLE) Phase ISL/LEN 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs) Day 1 up to Week 48
Trial Locations
- Locations (103)
EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin
🇩🇪Berlin, Germany
University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz
🇩🇪Bonn, Germany
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, District of Columbia, United States
Whitman-Walker Health
🇺🇸Washington, District of Columbia, United States
CAN Community Health
🇺🇸Sarasota, Florida, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, 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
St. Josephs Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Chiba University Hospital
🇯🇵Chiba, Japan
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
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Brooklyn Clinical Research Center
🇺🇸Brooklyn, New York, United States
New York Presbyterian Hospital
🇺🇸Flushing, 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
🇺🇸Salt Lake City, Utah, 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
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 Bicetre, France
Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite
🇫🇷Marseile, France
CHU Nice - Hopital Archet I
🇫🇷Nice, France
University of the Ryukyus Hospital
🇯🇵Okinawa, Japan
University of Puerto Rico School of Medicine
🇵🇷San Juan, Puerto Rico
Inselspital
🇨🇭Bern, Switzerland
Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz
🇩🇪Essen, Germany
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Universitaetsspital Zuerich
🇨🇭Zurich, Switzerland
ICH Study Center GmbH & Co.KG
🇩🇪Hamburg, Germany
Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80
🇩🇪Köln, Germany
National Center for Global Health and Medicine
🇯🇵Tokyo, Japan
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Hospital Universitario Regional de Malaga
🇪🇸Málaga, Spain
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka Fu, Japan
Osaka City General Hospital
🇯🇵Osaka-City, Japan
Hospital Universitario Vall d' Hebron
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario da Coruna
🇪🇸La Coruña, Spain
Kaohsuing Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsuing Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Taoyuan General Hospital
🇨🇳Taoyuan City, 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