DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

537

Participants

Timeline

Start Date

March 8, 2023

Primary Completion Date

October 13, 2025

Study Completion Date

August 5, 2029

Conditions
HIV-1 Infection
Interventions
DRUG

DOR/ISL

Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

DRUG

BIC/FTC/TAF

Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

DRUG

Placebo to DOR/ISL

Placebo tablet matched to DOR/ISL tablet taken by mouth.

DRUG

Placebo to BIC/FTC/TAF

Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Trial Locations (131)

1205

Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150), Geneva

2013

Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654), Johannesburg

2092

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661), Johannesburg

2193

Ezintsha-Clinical Research Site ( Site 6656), Johannesburg

3201

Human Sciences Research Council-Centre for Community Based Research ( Site 6664), Pietermaritzburg

3370

Qhakaza Mbokodo Research Clinic ( Site 6659), Ladysmith

4031

University Hospital Basel-Infectiology ( Site 8151), Basel

4052

Wentworth Hospital ( Site 6653), Durban

7500

Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657), Cape Town

7626

Be Part Yoluntu Centre ( Site 6650), Paarl

7925

Desmond Tutu Health Foundation ( Site 6651), Cape Town

9120

Hadassah Medical Center-Infecious Disease ( Site 6752), Jerusalem

9301

Josha Research ( Site 6652), Bloemfontein

10032

Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688), New York

10305

"Instituto Dermatológico y Cirugía de Piel Dr. Huberto Bogaert Díaz ( Site 8250)", Santo Domingo de Guzman

10330

HIV Netherlands Australia Thailand Research Collaboration ( Site 7851), Bangkok

10450

Hospital Pulau Pinang ( Site 7779), George Town

10461

Jacobi Medical Center ( Site 5683), The Bronx

10700

Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850), Bangkok

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251), Mexico City

20017

Washington Health Institute ( Site 5689), Washington D.C.

20146

ICH Study Center GmbH & Co. KG ( Site 6259), Hamburg

20246

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260), Hamburg

27401

Regional Center for Infectious Diseases ( Site 5687), Greensboro

28007

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353), Madrid

28015

Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357), Madrid

28034

Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 6355), Madrid

28046

Hospital Universitario La Paz ( Site 6354), Madrid

28204

Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675), Charlotte

29010

Hospital Universitario Virgen de la Victoria ( Site 6359), Málaga

30033

Metro Infectious Diseases Consultants L.L.C. ( Site 5653), Decatur

30308

Emory University and Grady Health System-Medicine ( Site 5690), Atlanta

Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673), Atlanta

30309

Atlanta I.D. Group ( Site 5680), Atlanta

31201

Mercer University, Department of Internal Medicine ( Site 5655), Macon

32803

Orlando Immunology Center ( Site 5654), Orlando

33133

AHF The Kinder Medical Group ( Site 5672), Miami

33140

AHF South Beach ( Site 5663), Miami Beach

33407

Triple O Research Institute, P.A ( Site 5666), West Palm Beach

34237

CAN Community Health - Sarasota ( Site 5668), Sarasota

34982

Midway Immunology and Research Center ( Site 5657), Ft. Pierce

40100

KEMRI-CMR-RCTP ( Site 8650), Kisumu

47000

Hospital Sungai Buloh ( Site 7778), Sungai Buloh

48072

Be Well Medical Center ( Site 5650), Berkley

48202

Henry Ford Hospital ( Site 5667), Detroit

50200

Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852, Chiang Mai

50586

Hospital Kuala Lumpur ( Site 7773), Kuala Lumpur

53127

Universitätsklinikum Bonn-Immunologie ( Site 6250), Bonn

59100

University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777), Lembah Pantai

59200

Tourcoing Hospital ( Site 6150), Tourcoing

60612

Rush University Medical Center-Infectious Disease ( Site 5671), Chicago

University of Illinois at Chicago-Project WISH ( Site 5685), Chicago

60613

Howard Brown Health Center-Clinical Research ( Site 5665), Chicago

64111

KC CARE Health Center-Clinical Trials ( Site 5670), Kansas City

68100

Hospital Selayang ( Site 7770), Batu Caves

75010

Hôpital Saint-Louis ( Site 6159), Paris

75013

Pitie Salpetriere University Hospital ( Site 6156), Paris

75018

Hôpital Bichat - Claude-Bernard ( Site 6162), Paris

75208

Prism Health North Texas, Oak Cliff Health Center ( Site 5660), Dallas

75246

North Texas Infectious Diseases Consultants, P.A ( Site 5651), Dallas

75571

Hôpital Saint Antoine ( Site 6158), Paris

75605

DCOL Center for Clinical Research ( Site 5664), Longview

76104

Texas Centers for Infectious Disease Associates ( Site 5656), Fort Worth

77401

St Hope Foundation ( Site 5659), Bellaire

78705

Central Texas Clinical Research ( Site 5661), Austin

79106

Universitaetsklinikum Freiburg ( Site 6256), Freiburg

79902

AXCES Research - Texas - El Paso ( Site 5692), El Paso

80246

Vivent Health ( Site 5694), Denver

80336

Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio, München

85015

Pueblo Family Physicians ( Site 5674), Phoenix

89106

Jubilee Clinical Research ( Site 5679), Las Vegas

Las Vegas Research Center ( Site 5691), Las Vegas

90036

Ruane Clinical Research Group, Inc ( Site 5658), Los Angeles

90211

Pacific Oaks Medical Group ( Site 5681), Beverly Hills

93000

Hôpital Avicenne ( Site 6160), Bobigny

93586

Sarawak General Hospital ( Site 7772), Kuching

110231

Hospital Universitario San Ignacio-Infectious ( Site 6053), Bogotá

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051), Bogotá

760032

Fundación Valle del Lili ( Site 6052), Santiago de Cali

3109601

Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751), Haifa

3465584

Clinica Universidad Catolica del Maule ( Site 5954), Talca

4781151

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955), Temuco

5262100

Sheba Medical Center-HIV unit ( Site 6753), Ramat Gan

6423906

Sourasky Medical Center ( Site 6754), Tel Aviv

7500710

Biomedica Research Group-Infectology ( Site 5951), Santiago

7770086

Espacio Eme ( Site 5952), Santiago

8330034

Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953), Santiago

8380420

Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950), Santiago

08844

ID Care ( Site 5676), Hillsborough

07102

Saint Michael's Medical Center ( Site 5682), Newark

45267-0405

University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662), Cincinnati

C1427CEA

Fundación Huésped ( Site 5850), CABA

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854), Mar del Plata

S2000PBJ

Instituto CAICI SRL ( Site 5852), Rosario

C1405CKC

Fundación IDEAA ( Site 5851), Buenos Aires

X5000JJS

Instituto Oulton ( Site 5853), Córdoba

L8S 1A4

Hamilton Health Sciences-Urgent Care Centre ( Site 5750), Hamilton

M5G 2C4

Toronto General Hospital ( Site 5753), Toronto

H2L 4P9

Clinique Medicale lActuel ( Site 5752), Montreal

H4A 3J1

McGill University Health Centre ( Site 5751), Montreal

S4P 0W5

Regina General Hospital ( Site 5754), Regina

08001

Ciensalud Ips S A S ( Site 6050), Barranquilla

080020

Clinica de la Costa S.A.S. ( Site 6055), Barranquilla

06202

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153), Nice

01001

CLINIPHARM ( Site 8352), Guatemala City

01009

Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350), Guatemala City

01010

CELAN,S.A ( Site 8351), Guatemala City

460-0001

National Hospital Organization Nagoya Medical Center ( Site 6953), Nagoya

160-0023

Tokyo Medical University Hospital ( Site 6954), Shinjuku-ku

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 6951), Shinjyuku-ku

540-0006

National Hospital Organization Osaka National Hospital ( Site 6952), Osaka

00200

CCR KEMRI (Center for Clinical Research) ( Site 8652), Nairobi

00202

PHRD KEMRI (Partners in Health Research & Development) ( Site 8651), Nairobi

05460

Hospital Sultanah Bahiyah ( Site 7776), Alor Star

00716

Ponce Medical School Foundation Inc. ( Site 7452), Ponce

00909

Clinical Research Puerto Rico ( Site 7450), San Juan

HOPE Clinical Research ( Site 7451), San Juan

0250

Madibeng Centre for Research ( Site 6660), Brits

03202

Hospital General Universitario de Elche-Infectius Disease ( Site 6358), Elche

08916

Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351), Badalona

08036

HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350), Barcelona

08907

Hospital Universitari de Bellvitge ( Site 6360), L'Hospitalet de Llobregat,Barcelona

08035

Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352), Barcelona

06230

Hacettepe Universite Hastaneleri ( Site 7650), Altindağ

06800

Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659), Ankara

BS10 5NB

Southmead Hospital ( Site 7952), Bristol

E1 1BB

Royal London Hospital ( Site 7951), London

M13 0FH

The Hathersage Centre ( Site 7953), Manchester

SE5 9RL

King's College Hospital ( Site 7950), London

WC1E 6JB

The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY