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 (99)

University of Alabama at Birmingham(UAB) 1917 Research Clinic

Birmingham, Alabama, United States, 35294

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

Yale University; School of Medicine; AIDS Program

New Haven, Connecticut, United States, 06510

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

BayCare Health System, Inc./St. Joseph's Hospital

Tampa, Florida, United States, 33607

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

Indiana CTSI Clinical Research Center

Indianapolis, Indiana, United States, 46202

Brigham and Womens's Hospital

Boston, Massachusetts, United States, 02115

Boston Medical Center

Boston, Massachusetts, United States, 02118

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

Boston, Massachusetts, United States, 02129

Be Well Medical Center

Berkley, Michigan, United States, 48072

Henry Ford Health

Detroit, Michigan, United States, 48202

Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States, 49503

ID Care

Hillsborough, New Jersey, United States, 08844

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

AXCES Research Group, LLC

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

NewYork-Presbyterian Queens

Flushing, New York, United States, 11355

Northwell Health/Division of Infectious Diseases

Manhasset, New York, United States, 11030

Duke University Health System(DUHS)

Durham, North Carolina, United States, 27710

ECU Health Leo Jenkins Cancer Building

Greenville, North Carolina, United States, 27834

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States, 45267

Prisma Health Midlands - Clinical Research Unit

Columbia, South Carolina, United States, 29203

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

Fundacion Huesped

Buenos Aires, Argentina, 1202

Helios Salud S.A.

Buenos Aires, Argentina, 1425

East Sydney Doctors

Darlinghurst, New South Wales, Australia, 2010

St Vincent's Hospital

Darlinghurst, New South Wales, Australia, 2010

Taylor Square Private Clinic

Surry Hills, New South Wales, Australia, 2010

Monash Health

Clayton, Victoria, Australia, 3168

Prahran Market Clinic

South Yarra, Victoria, Australia, 3141

University Hospital Hannover, Department for Rheumatology and Immunology

Hannover, Germany, 30625

Dr. Scholten & Schneeweiß GbR

Köln, Germany, 50674

Mannheimer Onkologie Praxis

Mannheim, Germany, 68167

MVZ München am Goetheplatz, MUC Research GmbH

Munchen, Germany, 80337

Chiba University Hospital

Chiba, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan, 460-0001

University of the Ryukyus Hospital

Okinawa, Japan

National Hospital Organization Osaka National Hospital

Osaka Fu, Japan, 540-0006

Osaka City General Hospital

Osaka-City, Japan, 534-0021

Tokyo Medical University Hospital

Tokyo, Japan, 160-0023

Japan Institute for Health Security National Center for Global Health and Medicine

Tokyo, Japan, 162-8655,

Amsterdam UMC, Iocation AMC

Amsterdam, Netherlands, 1105 az

Leiden University Medical Center (LUMC)

Leiden, Netherlands, 2333 ZA

Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych

Szczecin, Poland, 71-455

Wroclawskie Centrum Zorowia Samodzielny Publiczn Zaklad Opieki Zdrowotnej Sp Zoo Osrodek Profilaktyczno-Leczniczy Chorob Zakaznych I Terapi Uzaleznien

Wrocław, Poland, 50-136

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Maternal Infant Studies Center(CEMI)

San Juan, Puerto Rico, 00936-5067

Desmond Tutu Health Foundation, Clinical Trials Unit

Cape Town, South Africa, 7925

Perinatal HIV Research Unit

Soweto, South Africa, 2013

Hospital Germans Trias I Pujol

Barcelona, Spain, 08916

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Inselspital, Freiburgstrasse 20. Bern

Bern, Switzerland, 3010

Hopitaux Universitaires de Geneve

Geneva, Switzerland, 1205

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, 1011

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 80756

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060

National Taiwan University Hospital

Taipei City, Taiwan, 10002

Taoyuan General Hospital

Taoyuan City, Taiwan, 33004

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research

Bangkok, Thailand, 10330

Siriraj Hospital

Bangkok, Thailand, 10700

Chiang Mai University

Chiang Mai, Thailand, 50200

Khon Kaen University

Khon Kaen, Thailand, 40002

Bamrasnaradura Infectious Disease Institute

Nonthaburi, Thailand, 11000

Institute of HIV Research and Innovation (IHRI)

Pathumwan, Thailand, 10330

Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom, BN2 3EW

Harrison Wing Research Unit, Southwark Wing, Guy's Hospital (Guy's & St. Thomas' NHS Foundation Trust)

Great Maze Pond, United Kingdom, SE1 3RR

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

Caldecot Centre, King's College Hospital (King's College Hospital NHS Foundation Trust)

London, United Kingdom, SE5 9RJ

Mortimer Market Centre (Central and North West London NHS Foundation Trust)

London, United Kingdom, WC1E 6JB

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 (99)

University of Alabama at Birmingham(UAB) 1917 Research Clinic

Pueblo Family Physicians

Vv-Tmf-5366229

Ruane Clinical Research Group

BIOS Clinical Research

Vivent Health

University of Colorado Clinical and Translational Research Center

Yale University; School of Medicine; AIDS Program

Georgetown University Medical Center

Aids Healthcare Foundation - Northpoint

Midway Immunology and Research Center

CAN Community Health

Orlando Immunology Center

AHF Pensacola

CAN Community Health

BayCare Health System, Inc./St. Joseph's Hospital

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

Indiana CTSI Clinical Research Center

Brigham and Womens's Hospital

Boston Medical Center

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

Be Well Medical Center

Henry Ford Health

Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital

ID Care

Saint Michael's Medical Center

AXCES Research Group, LLC

Jacobi Medical Center

Montefiore Medical Center

NewYork-Presbyterian Queens

Northwell Health/Division of Infectious Diseases

Duke University Health System(DUHS)

ECU Health Leo Jenkins Cancer Building

Rosedale Health and Wellness

University of Cincinnati College of Medicine

Prisma Health Midlands - Clinical Research Unit

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

Fundacion Huesped

Helios Salud S.A.

East Sydney Doctors

St Vincent's Hospital

Taylor Square Private Clinic

Monash Health

Prahran Market Clinic

University Hospital Hannover, Department for Rheumatology and Immunology

Dr. Scholten & Schneeweiß GbR

Mannheimer Onkologie Praxis

MVZ München am Goetheplatz, MUC Research GmbH

Chiba University Hospital

National Hospital Organization Nagoya Medical Center

University of the Ryukyus Hospital

National Hospital Organization Osaka National Hospital

Osaka City General Hospital

Tokyo Medical University Hospital

Japan Institute for Health Security National Center for Global Health and Medicine

Amsterdam UMC, Iocation AMC

Leiden University Medical Center (LUMC)

Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych