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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

October 8, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

August 31, 2030

Conditions
HIV-1-Infection
Interventions
DRUG

ISL/LEN

Tablet administered orally

DRUG

Antiretroviral Combinations

2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.

Trial Locations (100)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1072

Hospital General de Agudos Dr. J.M. Ramos Mejia, Buenos Aires

1202

Fundacion Huesped, Buenos Aires

1205

Hopitaux Universitaires de Geneve, Geneva

1425

Helios Salud S.A., Buenos Aires

2010

East Sydney Doctors, Darlinghurst

St Vincent's Hospital, Darlinghurst

Taylor Square Private Clinic, Surry Hills

2013

Perinatal HIV Research Unit, Soweto

3010

Inselspital, Freiburgstrasse 20. Bern, Bern

3141

Prahran Market Clinic, South Yarra

3168

Monash Health, Clayton

7925

Desmond Tutu Health Foundation, Clinical Trials Unit, Cape Town

10002

National Taiwan University Hospital, Taipei

10330

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

Institute of HIV Research and Innovation (IHRI), Pathumwan

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

10700

Siriraj Hospital, Bangkok

11000

Bamrasnaradura Infectious Disease Institute, Nonthaburi

11030

Northwell Health/Division of Infectious Diseases, Manhasset

11355

NewYork-Presbyterian Queens, Flushing

20007

Georgetown University Medical Center, Washington D.C.

22003

Clinical Alliance for Research& Education - Infectious Diseases, LLC, Annandale

22060

Far Eastern Memorial Hospital, New Taipei City

27710

Duke University Health System(DUHS), Durham

27834

ECU Health Leo Jenkins Cancer Building, Greenville

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28078

Rosedale Health and Wellness, Huntersville

29203

Prisma Health Midlands - Clinical Research Unit, Columbia

30033

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

30625

University Hospital Hannover, Department for Rheumatology and Immunology, Hanover

31201

Mercer University, Department of Internal Medicine, Macon

31401

Chatham County Health Department, Savannah

32503

AHF Pensacola, Pensacola

32803

Orlando Immunology Center, Orlando

33004

Taoyuan General Hospital, Taoyuan

33055

CAN Community Health, Miami Gardens

33308

Aids Healthcare Foundation - Northpoint, Fort Lauderdale

33401

Triple O Research Institute, P.A., West Palm Beach

33607

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

34237

CAN Community Health, Sarasota

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham(UAB) 1917 Research Clinic, Birmingham

40002

Khon Kaen University, Khon Kaen

41013

Hospital Universitario Virgen del Rocio, Seville

45267

University of Cincinnati College of Medicine, Cincinnati

46202

Indiana CTSI Clinical Research Center, Indianapolis

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health, Detroit

49503

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

50200

Chiang Mai University, Chiang Mai

50674

Dr. Scholten & Schneeweiß GbR, Cologne

60613

Howard Brown Health Center, Chicago

68167

Mannheimer Onkologie Praxis, Mannheim

75246

North Texas Infectious Diseases Consultants, PA, Dallas

75605

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

76104

Texas Centers for Infectious Disease Associates, Fort Worth

77098

The Crofoot Research Center, INC., Houston

78705

Central Texas Clinical Research, Austin

79902

AXCES Research Group, LLC, El Paso

80246

Vivent Health, Denver

80262

University of Colorado Clinical and Translational Research Center, Denver

80337

MVZ München am Goetheplatz, MUC Research GmbH, München

80756

Kaohsiung Medical University Hospital, Kaohsiung City

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

84102

AXCES Research Group, LLC, Salt Lake City

85015

Pueblo Family Physicians, Phoenix

87505

AXCES Research Group, LLC, Santa Fe

90027

Vv-Tmf-5366229, Los Angeles

90036

Ruane Clinical Research Group, Los Angeles

92262

BIOS Clinical Research, Palm Springs

99202

MultiCare Rockwood Main Clinic, Spokane

06510

Yale University; School of Medicine; AIDS Program, New Haven

02115

Brigham and Womens's Hospital, Boston

02118

Boston Medical Center, Boston

02129

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

08844

ID Care, Hillsborough

07102

Saint Michael's Medical Center, Newark

Unknown

Chiba University Hospital, Chiba

University of the Ryukyus Hospital, Okinawa

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

534-0021

Osaka City General Hospital, Osaka

540-0006

National Hospital Organization Osaka National Hospital, Osaka Fu

160-0023

Tokyo Medical University Hospital, Tokyo

162-8655,

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

1105 az

Amsterdam UMC, Iocation AMC, Amsterdam

2333 ZA

Leiden University Medical Center (LUMC), Leiden

71-455

Samodzielny Publiczny Wojewodzig Szpital Zespolony Poradnia Nabytych Niedoborow Immunologicznych, Szczecin

50-136

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

00909

HOPE Clinical Research, San Juan

00936-5067

Maternal Infant Studies Center(CEMI), San Juan

08916

Hospital Germans Trias I Pujol, Barcelona

BN2 3EW

Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust, Brighton

SE1 3RR

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

E1 1BB.

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust), London

NW3 2QG

Royal Free Hospital (Royal Free London NHS Foundation Trust), London

SE5 9RJ

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

WC1E 6JB

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT06630299 - Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 | Biotech Hunter | Biotech Hunter