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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

609

Participants

Timeline

Start Date

October 9, 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

B/F/TAF

Tablet administered orally

DRUG

PTM B/F/TAF

Tablet administered orally

DRUG

PTM ISL/LEN

Tablet administered orally

Trial Locations (106)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1202

Fundacion Huesped, Buenos Aires

1425

Helios Salud S.A., Buenos Aires

2010

East Sydney Doctors, Darlinghurst

St Vincent's Hospital, Darlinghurst

Taylor Square Private Clinic, Surry Hills

3010

Inselspital, Bern

3141

Prahran Market Private Clinic, South Yarra

3168

Monash Health, Clayton

6203

CHU Nice - Hopital Archet I, Nice

8091

Universitaetsspital Zuerich, Zurich

10002

National Taiwan University Hospital, Taipei

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

10787

EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin, Berlin

11226

Brooklyn Clinical Research Center, Brooklyn

11355

New York Presbyterian Hospital, Flushing

13009

Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite, Marseile

15006

Complexo Hospitalario Universitario da Coruna, A Coruña

20007

Georgetown University, Washington D.C.

20009

Whitman-Walker Health, Washington D.C.

20146

ICH Study Center GmbH & Co.KG, Hamburg

22003

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

22060

Far Eastern Memorial Hospital, New Taipei City

27599

CTRC University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University, Durham

27858

Brody School of Medicine at East Carolina University Adult Specialty Care, Greenville

28078

Rosedale Health and Wellness, Huntersville

28207

Atrium Health Infectious Disease Kenilworth, Charlotte

29010

Hospital Universitario Regional de Malaga, Málaga

29203

Prisma Health/USC, Columbia

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

Emory University, Atlanta

31201

Mercer University, Macon

31401

Chatham CARE Center, Savannah

32504

AHF (AIDS Healthcare Foundation) - Pensacola Research, Pensacola

32803

Orlando Immunology Center, Orlando

33004

Taoyuan General Hospital, Taoyuan

33055

CAN Community Health, Miami Gardens

33075

CHU Bordeaux - Hopital Saint André, Bourdeaux

33316

CAN Community Health, Fort Lauderdale

33334

Midland Research Group, Inc., Oakland Park

33607

St. Josephs Comprehensive Research Institute, Tampa

34237

CAN Community Health, Sarasota

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

43210

Ohio State University, Columbus

44109

MetroHealth Medical Center, Cleveland

45122

Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz, Essen

45267

University of Cincinnati, Cincinnati

46202

Indiana University School of Medicine, Indianapolis

48072

Be Well Medical Center, Berkley

49503

Trinity Health, Grand Rapids

53127

University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz, Bonn

53705

University of Wisconsin-Madison, Madison

60613

Howard Brown Health, Chicago

64111

KC CARE Health Center, Kansas City

75246

North Texas Infectious Diseases Consultants, Dallas

75605

DCOL Center for Clinical Research, 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- Anschutz Medical Campus - PPDS, Denver

80756

Kaohsuing Medical University Hospital, Kaohsiung City

81362

Kaohsuing Veterans General Hospital, Kaohsiung City

84102

AXCES Research Group, LLC, Salt Lake City

85015

Pueblo Family Physicians, Phoenix

87505

AXCES Research Group - Albuquerque, Santa Fe

90027

Kaiser Permanente Southern California, Los Angeles

90036

Ruane Clinical Research Group, Inc, Los Angeles

90069

Mills Clinical Research, Los Angeles

92262

BIOS Clinical Research, Palm Springs

94102

Optimus Medical Group, San Francisco

94270

AP-HP-Hopital Bicétre, Le Kremlin-Bicêtre

98104

Peter Shalit MD, Seattle

99202

MultiCare Institute for Research & Innovation, Spokane

06510

Yale University, New Haven

02115

The Brigham and Women's Hospital, Inc., Boston

02118

Boston Medical Center, Boston

02129

Community Research Initiative, Boston

08844

ID CARE, Hillsborough

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

H2L 0B1

Clinique de médecine Urbaine du Quartier Latin, Montreal

H4A 3J1

McGill University Health Centr, Montreal

V6Z 2T1

Spectrum Health, Vancouver

Unknown

"Uniklinik Kéin, Innere Medizin , , Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80"

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

00909

Clinical Research Puerto Rico, San Juan

00935

University of Puerto Rico School of Medicine, San Juan

08035

Hospital Universitario Vall d' Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

B9 5SS

Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust), Birmingham

BN2 3EW

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust), Brighton

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

SW10 9TH

Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster 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

NCT06630286 - Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 | Biotech Hunter | Biotech Hunter