Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

577

Participants

Timeline

Start Date

March 25, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2029

Conditions
HIV-1-infection
Interventions
DRUG

Bictegravir

Tablets administered orally without regard to food

DRUG

Lenacapavir

Tablets administered orally without regard to food

DRUG

B/F/TAF

Tablets administered orally without regard to food

DRUG

Placebo to match B/F/TAF

Tablets administered orally without regard to food

DRUG

Placebo to match BIC/LEN

Tablets administered orally without regard to food

Trial Locations (104)

100

National Taiwan University Hospital, Taipei

2011

Taylor Square Private Clinic, Darlinghurst

3004

Alfred Hospital(Alfred Health), Melbourne

3141

Prahran Market Clinic, South Yarra

4103

Hospital Universitario Virgen del Rocio - PPDS, Seville

6170

ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan, Mexico City

8916

Hospital Universitario Germans Trias i Pujol, Badalona Barcelona

10117

Novopraxis Berlin, Berlin

10467

Montefiore Medical Center, The Bronx

11355

New York-Presbyterian Queens, Flushing

19107

Philadelphia FIGHT Community Health Centers, Philadelphia

20090

Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo, Monza

20127

IRCCS Ospedale San Raffaele, Milan

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

22003

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

25123

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN, Brescia

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

27858

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

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28078

Rosedale Health and Wellness, Huntersville

29425

Medical University of South Carolina (MUSC) Research Nexus, Charleston

30033

Infectious Disease Specialists of Atlanta, Decatur

31201

Mercer University, Department of Internal Medicine, Macon

32503

AHF Pensacola, Pensacola

32720

Midland Florida Infectious Diseases Specialists, PL - Orange City, DeLand

32803

Orlando Immunology Center, Orlando

32806

Bliss Healthcare, Orlando

33004

Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan

33016

Floridian Clinical Research, Miami Lakes

33133

AIDS Healthcare Foundation - The Kinder Medical Group, Miami

33136

Schiff Center for liver Diseases/University of Miami, Miami

33308

Therafirst Medical Center, Fort Lauderdale

33316

CAN Community Health, Fort Lauderdale

33407

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

34237

CAN community Health, Sarasota

34982

Midway Immunology and Research Center, Ft. Pierce

41944

Kyungpook National University Hospital, Daegu

46014

Consorcio Hospital General Universitario de Valencia, Valencia

48072

Be Well Medical Center, Berkeley

48202

Henry Ford Health, Detroit

50668

Praxis am Ebertplatz, Cologne

52062

Praxis Dr. Knechten, Aachen

60590

Universitätsklinikum Frankfurt, Frankfurt

63139

Southampton Community Healthcare, Inc., St Louis

64111

KC Care health Center, Kansas City

71122

Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia), Foggia

75208

AIDS Arms, Inc. DBA Prism Health North Texas, Dallas

75246

North Texas Infectious Diseases Consultants, PA, Dallas

76104

Texas Centers for Infectious Disease Associates, Fort Worth

77098

The Crofoot research Center, INC., Houston

77401

St Hope Foundation, Inc., Bellaire

78705

Central Texas Clinical Research, Austin

79902

AXCES Research Group, LLC, El Paso

80204

Public Health Institute at Denver Health, Denver

80336

LMU Klinikum der Universität, Munich

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

81675

Klinikum rechts der Isar der Technischen Universitaet Muenchen, München

84102

AXCES Research Group, LLC, Salt Lake City

85015

Pueblo Family Physicians, Phoenix

87505

AXCES Research Group, LLC, Santa Fe

90036

Ruane Clinical Research Group Inc., Los Angeles

90046

Mills Clinical Research, West Hollywood

90211

Pacific Oaks Medical Group, Beverly Hills

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92103

UCSD Anti Viral Research Centre (AVRC), San Diego

92262

BIOS Clinical Research, Palm Springs

94609

Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care, Oakland

97070

Unidad de Atencion Medica e Investigacion en Salud, Mérida

98104

Peter Shalit MD, Seattle

98405

Community Health care, Tacoma

06510

Yale University School of Medicine (study visits), New Haven

01105

Claudia T Martorell MD LLC dba The Research Institute, Springfield

08844

ID Care, LLC, Hillsborough

07102

Saint Michael's Medical Center, Newark

07103

New Jersey Medical School - Clinical Research Center, Newark

08244

South Jersey Infectious Disease, Somers Point

C1141ACG

Helios Salud S.A., Buenos Aires

C1202ABB

Fundacion Huesped, Buenos Aires

S2000PBJ,

Instituto CAICI SRL, Santa Fe

H4A 3J1

Chronic Viral Illness Service/McGill University Health Centre (MUHC), Decarie Montreal

H2L 4P9

Clinique Médicale l'Actuel, Montreal

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

S4P 0W5

Regina General Hospital, Regina

V6Z1Y6

St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC), Vancouver

V8W 1M8

Cool Aid Community Health Centre, Victoria

Unknown

Instituto Dominicano de Estudios Virologicos - IDEV, Santo Domingo

00149

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Roma

00168

Fondazione Policlinico Universitario A Gemelli-Rome, Roma

460-0001

National Hospital Organization Nagoya Medical Center, Aichi

540-0006

National Hospital Organization Osaka National Hospital, Osaka

162-0052

Center Hospital of the National Center for Global Health and Medicine, Tokyo

00909

HOPE Clinical Research, San Juan

00935

Proyecto ACTU, San Juan

*04564

National Medical Center, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

137-701

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

L7 8XP

Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital, Liverpool

SE5 9RS

King's College Hospital, Weston Education Centre, London

SW109NH

Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital, London

W2 1NY

St Mary's Hospital - PPDS, London

WC1E 6JB

Mortimer Market Centre, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT06333808 - Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy | Biotech Hunter | Biotech Hunter