Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

PHASE3CompletedINTERVENTIONAL
Enrollment

599

Participants

Timeline

Start Date

February 28, 2020

Primary Completion Date

November 17, 2022

Study Completion Date

January 29, 2025

Conditions
HIV-1 Infection
Interventions
DRUG

DOR/ISL

100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.

DRUG

BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg FDC tablet taken once daily by mouth.

DRUG

Placebo to BIC/FTC/TAF

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

DRUG

Placebo to DOR/ISL

Placebo tablet matched to DOR/ISL taken by mouth.

Trial Locations (95)

100

National Taiwan University Hospital ( Site 7100), Taipei

1862

Chris Hani Baragwanath Hospital - ICU ( Site 6608), Johannesburg

2041

Wits Health Consortium. Clinical HIV Research Unit ( Site 6614), Johannesburg

2193

Ezintsha ( Site 6609), Johannesburg

4052

Wentworth Hospital ( Site 6607), Durban

7500

Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617), Cape Town

7646

Be Part Yoluntu Centre ( Site 6603), Mbekweni, Paarl

7925

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613), Cape Town

9301

JOSHA Research ( Site 6605), Bloemfontein

10149

Ospedale Amedeo di Savoia ( Site 6414), Turin

10787

EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208), Berlin

19104

University of Pennsylvania ( Site 5630), Philadelphia

20122

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401), Milan

20127

Salute San Raffaele ( Site 6402), Milan

20142

Azienda Ospedaliera San Paolo ( Site 6403), Milan

20157

ASST Fatebenefratelli-Ospedale Sacco ( Site 6400), Milan

20246

Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210), Hamburg

20900

Ospedale San Gerardo ASST Monza ( Site 6412), Monza

21079

Hopital Francois Mitterrand ( Site 6119), Dijon

24127

ASST Papa Giovanni XXIII ( Site 6411), Bergamo

27100

IRCCS Policlinico San Matteo ( Site 6410), Pavia

28007

Hospital General Universitario Gregorio Maranon ( Site 6303), Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz ( Site 6307), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 6305), Madrid

28046

Hospital Universitario La Paz ( Site 6304), Madrid

29010

Hospital Universitario Virgen de la Victoria ( Site 6309), Málaga

30033

Infectious Disease Specialists Of Atlanta PC ( Site 5608), Decatur

31904

Columbus Regional Research Institute ( Site 5616), Columbus

32803

Orlando Immunology Center ( Site 5613), Orlando

33016

Floridian Clinical Research, LLC ( Site 5625), Miami Lakes

33076

CHU de Bordeaux. Hopital Pellegrin ( Site 6116), Bordeaux

33133

The Kinder Medical Group ( Site 5615), Miami

33407

Triple O Research Institute, P.A. ( Site 5621), West Palm Beach

34237

CAN Community Health ( Site 5627), Sarasota

34982

Midway Immunology and Research ( Site 5622), Ft. Pierce

35222

University of Alabama at Birmingham 1917 Research Clinic ( Site 5610), Birmingham

41124

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404), Modena

45000

Centre Hospitalier Regional du Orleans ( Site 6108), Orléans

53127

Universitaetsklinikum Bonn ( Site 6200), Bonn

55415

Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633), Minneapolis

59208

Centre Hospitalier de Tourcoing ( Site 6100), Tourcoing

60596

Infektiologikum ( Site 6201), Frankfurt am Main

64111

Kansas City CARE Clinic ( Site 5607), Kansas City

64239

Sourasky Medical Center ( Site 6705), Tel Aviv

65129

Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413), Pescara

69004

Hopital de la Croix-Rousse ( Site 6127), Lyon

70403

National Cheng Kung University Hospital ( Site 7101), Tainan City

75010

A.P.H. Paris, Hopital Saint Louis ( Site 6114), Paris

75012

Hopital Saint-Antoine ( Site 6113), Paris

75013

Hopital Pitie Salpetriere ( Site 6111), Paris

75018

A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124), Paris

75246

North Texas ID Consultants, PA ( Site 5604), Dallas

76104

Texas Centers for Infectious Disease Associates P.A. ( Site 5619), Fort Worth

77401

Saint Hope Foundation, Inc. ( Site 5629), Bellaire

79106

Universitaetsklinik Freiburg ( Site 6206), Freiburg im Breisgau

80131

A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407), Napoli

80336

Klinikum der LMU München ( Site 6204), Munich

80337

MVZ Munchen am Goetheplatz ( Site 6202), Munich

81362

Kaohsiung Veterans General Hospital ( Site 7102), Kaohsiung City

85015

Pueblo Family Physicians ( Site 5606), Phoenix

90036

Ruane Clinical Research Group, Inc. ( Site 5624), Los Angeles

93000

Hopital Avicenne ( Site 6102), Bobigny

110231

Hospital Universitario San Ignacio ( Site 6005), Bogotá

111321

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006), Bogotá

760032

Fundacion Valle del Lili ( Site 6001), Santiago de Cali

3109601

Rambam Medical Center ( Site 6701), Haifa

3460000

Clinica Universidad Catolica del Maule ( Site 5909), Talca

4781151

Hospital Dr. Hernan Henriquez Aravena ( Site 5905), Temuco

5265601

Chaim Sheba Medical Center. ( Site 6704), Ramat Gan

7560994

Clinica Arauco Salud ( Site 5900), Santiago

7610001

Kaplan Medical Center ( Site 6700), Rehovot

8331150

Hospital Clinico de la Universidad Catolica ( Site 5903), Santiago

8360159

Fundacion Arriaran ( Site 5901), Santiago

8910259

Centro Cardiovascular Cardiosur ( Site 5907), Santiago

9112001

Hadassah Ein Kerem Medical Center ( Site 6702), Jerusalem

C1141ACG

Helios Salud S.A. ( Site 5802), Buenos Aires

C1405CKC

IDEAA Foundation ( Site 5807), Buenos Aires

C1202ABB

Fundación Huesped ( Site 5801), C.a.b.a

S2000PBJ

Instituto CAICI ( Site 5803), Rosario

X5000JJS

Instituto Oulton ( Site 5804), Córdoba

L8S 14K

Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703), Hamilton

M5G 2N2

Toronto General Hospital - University Health Network ( Site 5705), Toronto

H2L 4P9

Clinique Medicale L Actuel ( Site 5714), Montreal

H4A 3J1

McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702), Montreal

00149

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405), Roma

460-0001

National Hospital Organization Nagoya Medical Center ( Site 6903), Nagoya

860-8556

Kumamoto University Hospital ( Site 6905), Kumamoto

540-0006

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69, Osaka

160-0023

Tokyo Medical University Hospital ( Site 6904), Tokyo

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 6901), Tokyo

03202

Hospital General de Elche ( Site 6308), Elche

08916

Hospital Universitari Germans Trias i Pujol ( Site 6301), Badalona

08907

Hospital Universitari de Bellvitge ( Site 6312), LHospitalet de Llobregat

08035

Hospital Vall D Hebron ( Site 6302), Barcelona

08036

Hospital Clinic i Provincial ( Site 6300), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04233879 - Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) | Biotech Hunter | Biotech Hunter