Study Details

PROTOCOL SUMMARY

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care 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 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

ISL/LEN, Antiretroviral Combinations

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 weeks 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.
Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
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 (ALT) > 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 (38)

Pueblo Family Physicians

Phoenix, Arizona, United States, 85015

Vv-Tmf-5366229

Los Angeles, California, United States, 90027

Ruane Clinical Research Group

Los Angeles, California, United States, 90036

BIOS Clinical Research

Palm Springs, California, United States, 92262

Vivent Health

Denver, Colorado, United States, 80246

University of Colorado Clinical and Translational Research Center

Denver, Colorado, United States, 80262

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Aids Healthcare Foundation - Northpoint

Fort Lauderdale, Florida, United States, 33308

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

CAN Community Health

Miami Gardens, Florida, United States, 33055

Orlando Immunology Center

Orlando, Florida, United States, 32803

AHF Pensacola

Pensacola, Florida, United States, 32503

CAN Community Health

Sarasota, Florida, United States, 34237

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33401

Metro Infectious Disease Consultants, P.L.L.C.

Decatur, Georgia, United States, 30033

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

Chatham County Health Department

Savannah, Georgia, United States, 31401

Howard Brown Health Center

Chicago, Illinois, United States, 60613

Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)

Boston, Massachusetts, United States, 02129

ID Care

Hillsborough, New Jersey, United States, 08844

AXCES Research Group, LLC

Santa Fe, New Mexico, United States, 87505

Jacobi Medical Center

Bronx, New York, United States, 10461

ECU Health Leo Jenkins Cancer Building

Greenville, North Carolina, United States, 27834

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

Central Texas Clinical Research

Austin, Texas, United States, 78705

North Texas Infectious Diseases Consultants, PA

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

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

Longview, Texas, United States, 75605

AXCES Research Group, LLC

Salt Lake City, Utah, United States, 84102

Clinical Alliance for Research& Education - Infectious Diseases, LLC

Annandale, Virginia, United States, 22003

MultiCare Rockwood Main Clinic

Spokane, Washington, United States, 99202

East Sydney Doctors

Darlinghurst, New South Wales, Australia, 2010

Taylor Square Private Clinic

Darlinghurst, New South Wales, Australia, 2011

Prahran Market Clinic

South Yarra, Victoria, Australia, 3141

National Hospital Organization Osaka National Hospital

Osaka Fu, Japan, 540-0006

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (ISLEND-2)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (38)

Pueblo Family Physicians

Vv-Tmf-5366229

Ruane Clinical Research Group

BIOS Clinical Research

Vivent Health

University of Colorado Clinical and Translational Research Center

Georgetown University Medical Center

Aids Healthcare Foundation - Northpoint

Midway Immunology and Research Center

CAN Community Health

Orlando Immunology Center

AHF Pensacola

CAN Community Health

Triple O Research Institute, P.A.

Metro Infectious Disease Consultants, P.L.L.C.

Mercer University, Department of Internal Medicine

Chatham County Health Department

Howard Brown Health Center

Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)

ID Care

AXCES Research Group, LLC

Jacobi Medical Center

ECU Health Leo Jenkins Cancer Building

Rosedale Health and Wellness

Central Texas Clinical Research

North Texas Infectious Diseases Consultants, PA

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot Research Center, INC.

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

AXCES Research Group, LLC

Clinical Alliance for Research& Education - Infectious Diseases, LLC

MultiCare Rockwood Main Clinic

East Sydney Doctors

Taylor Square Private Clinic

Prahran Market Clinic

National Hospital Organization Osaka National Hospital

HOPE Clinical Research