Study Details

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2024 - June 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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 (53)

Pueblo Family Physicians

Phoenix, Arizona, United States, 85015

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

Vivent Health

Denver, Colorado, United States, 80246

University of Colorado Clinical and Translational Research Center

Denver, Colorado, United States, 80262

Georgetown University

Washington, District of Columbia, United States, 20007

CAN Community Health

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

CAN Community Health

Miami Gardens, Florida, United States, 33055

CAN Community Health/Midland

Oakland Park, Florida, United States, 33334

Orlando Immunology Center

Orlando, Florida, United States, 32803

AHF (AIDS Healthcare Foundation) - Pensacola Research

Pensacola, Florida, United States, 32504

CAN Community Health

Sarasota, Florida, United States, 34237

Emory University

Atlanta, Georgia, United States, 30308

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Mercer University

Macon, Georgia, United States, 31201

Chatham CARE Center

Savannah, Georgia, United States, 31401

Howard Brown Health

Chicago, Illinois, United States, 60613

Community Research Initiative

Boston, Massachusetts, United States, 02129

Be Well Medical Center

Berkley, Michigan, United States, 48072

KC CARE Health Center

Kansas City, Missouri, United States, 64111

ID CARE

Hillsborough, New Jersey, United States, 08844

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

AXCES Research Group - Albuquerque

Santa Fe, New Mexico, United States, 87505

Jacobi Medical Center

Bronx, New York, United States, 10461

Montefiore Medical Center

Bronx, New York, United States, 10467

Swift Clinical Research Group, Inc.

Brooklyn, New York, United States, 11226

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

Ohio State University

Columbus, Ohio, United States, 43210

Central Texas Clinical Research

Austin, Texas, United States, 78705

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

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

AXCES Research Group, LLC

Salt Lake City, Utah, United States, 84102

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

Annandale, Virginia, United States, 22003

Peter Shalit MD

Seattle, Washington, United States, 98104

MultiCare Institute for Research & Innovation

Spokane, Washington, United States, 99202

East Sydney Doctors

Darlinghurst, New South Wales, Australia, 2010

Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia, 2011

Monash Health

Clayton, Victoria, Australia, 3168

Prahran Market Private Clinic

South Yarra, Victoria, Australia, 3141

Clinique de médecine Urbaine du Quartier Latin

Montreal, Canada, H2L 0B1

Spectrum Health

Vancouver, Canada, V6Z 2T1

National Hospital Organization Osaka National Hospital

Osaka Fu, Japan, 540-0006

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (53)

Pueblo Family Physicians

Kaiser Permanente Southern California

Ruane Clinical Research Group, Inc

Mills Clinical Research

BIOS Clinical Research

Optimus Medical Group

Vivent Health

University of Colorado Clinical and Translational Research Center

Georgetown University

CAN Community Health

Midway Immunology and Research Center

CAN Community Health

CAN Community Health/Midland

Orlando Immunology Center

AHF (AIDS Healthcare Foundation) - Pensacola Research

CAN Community Health

Emory University

Infectious Disease Specialists of Atlanta

Mercer University

Chatham CARE Center

Howard Brown Health

Community Research Initiative

Be Well Medical Center

KC CARE Health Center

ID CARE

South Jersey Infectious Disease

AXCES Research Group - Albuquerque

Jacobi Medical Center

Montefiore Medical Center

Swift Clinical Research Group, Inc.

CTRC University of North Carolina at Chapel Hill

Atrium Health Infectious Disease Kenilworth

Brody School of Medicine at East Carolina University Adult Specialty Care

Rosedale Health and Wellness

Ohio State University

Central Texas Clinical Research

North Texas Infectious Diseases Consultants

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot Research Center, INC.

DCOL Center for Clinical Research

AXCES Research Group, LLC

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

Peter Shalit MD

MultiCare Institute for Research & Innovation

East Sydney Doctors

Taylor Square Private Clinic

Monash Health

Prahran Market Private Clinic

Clinique de médecine Urbaine du Quartier Latin

Spectrum Health

National Hospital Organization Osaka National Hospital

Clinical Research Puerto Rico