OVERVIEW
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) (ISLEND-1)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
October 2024 - April 2026
Study Type
Interventional
Study Phase
Phase 3
Product
ISL/LEN, B/F/TAF, PTM B/F/TAF, PTM ISL/LEN
Eligibility information
Inclusion criteria
- HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
- 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 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:
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (106)
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Kaiser Permanente Southern California
Los Angeles, California, United States, 90027
Ruane Clinical Research Group, Inc
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
BIOS Clinical Research
Palm Springs, California, United States, 92262
Optimus Medical Group
San Francisco, California, United States, 94102
University of Colorado- Anschutz Medical Campus - PPDS
Denver, Colorado, United States, 80262
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Whitman-Walker Health
Washington D.C., District of Columbia, United States, 20009
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Midland Research Group, Inc.
Oakland Park, Florida, United States, 33334
AHF (AIDS Healthcare Foundation) - Pensacola Research
Pensacola, Florida, United States, 32504
St. Josephs Comprehensive Research Institute
Tampa, Florida, United States, 33607
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, United States, 02115
Community Research Initiative
Boston, Massachusetts, United States, 02129
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
AXCES Research Group - Albuquerque
Santa Fe, New Mexico, United States, 87505
Brooklyn Clinical Research Center
Brooklyn, New York, United States, 11226
New York Presbyterian Hospital
Flushing, New York, United States, 11355
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Atrium Health Infectious Disease Kenilworth
Charlotte, North Carolina, United States, 28207
Brody School of Medicine at East Carolina University Adult Specialty Care
Greenville, North Carolina, United States, 27858
Rosedale Health and Wellness
Huntersville, North Carolina, United States, 28078
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States, 76104
The Crofoot Research Center, INC.
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States, 22003
MultiCare Institute for Research & Innovation
Spokane, Washington, United States, 99202
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia, 2010
Clinique de médecine Urbaine du Quartier Latin
Montreal, Canada, H2L 0B1
Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite
Marseile, France, 13009
EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin
Berlin, Germany, 10787
University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz
Bonn, Germany, 53127
Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz
Essen, Germany, 45122
National Hospital Organization Nagoya Medical Center
Nagoya, Japan, 460-0001
National Hospital Organization Osaka National Hospital
Osaka Fu, Japan, 540-0006
Japan Institute for Health Security National Center for Global Health and Medicine
Tokyo, Japan, 162-8655,
University of Puerto Rico School of Medicine
San Juan, PR, Puerto Rico, 00935
Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)
Birmingham, United Kingdom, B9 5SS
Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)
Brighton, United Kingdom, BN2 3EW
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)
London, United Kingdom, E1 1BB.
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, United Kingdom, NW3 2QG
Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)
London, United Kingdom, SW10 9TH
Mortimer Market Centre (Central and North West London NHS Foundation Trust)
London, United Kingdom, WC1E 6JB
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