Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

PHASE3CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 18, 2020

Primary Completion Date

November 21, 2022

Study Completion Date

November 1, 2023

Conditions
HIV-1 Infection
Interventions
DRUG

ISL

ISL 0.75 mg capsule taken by mouth.

DRUG

DOR

DOR 100 mg tablet taken by mouth.

DRUG

DOR/ISL

100 mg DOR/0.75 mg ISL FDC taken by mouth.

DRUG

Placebo to ISL

Placebo capsule matched to ISL taken by mouth.

DRUG

Placebo to DOR

Placebo tablet matched to DOR taken by mouth.

Trial Locations (98)

2000

Holdsworth House Medical Practice ( Site 5300), Sydney

2010

St Vincent's Hospital ( Site 5309), Sydney

2041

Wits Clinical HIV Research Unit ( Site 4804), Johannesburg

2193

Ezintsha ( Site 4806), Johannesburg

3004

The Alfred Hospital ( Site 5304), Melbourne

3168

Monash Health-Monash Medical Centre ( Site 5313), Clayton

4006

Holdsworth House Medical Practice - Brisbane ( Site 5312), Brisbane

4013

King Edward Hospital ( Site 4802), Durban

9301

FARMOVS ( Site 4805), Bloemfontein

10029

Icahn School of Medicine at Mount Sinai ( Site 4000), New York

10439

ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603), Berlin

10787

EPIMED GmbH ( Site 4608), Berlin

13003

Hopital Europeen Marseille ( Site 4717), Marseille

15001

Via Libre ( Site 4500), Lima

15046

INMENSA ( Site 4506), Lima

15081

Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501), Lima

20007

Georgetown University Hospital ( Site 4015), Washington D.C.

20122

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001), Milan

20127

Universita' Vita Salute. Ospedale San Raffaele ( Site 5002), Milan

20142

Azienda Ospedaliera San Paolo ( Site 5003), Milan

20146

ICH Study Center GmbH & Co.KG ( Site 4609), Hamburg

20157

ASST Fatebenefratelli-Ospedale Sacco ( Site 5000), Milan

20900

Ospedale San Gerardo ASST Monza ( Site 5012), Monza

21201

University of Maryland ( Site 4023), Baltimore

23222

MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618), Berezina

27100

IRCCS Policlinico San Matteo ( Site 5010), Pavia

27599

University of North Carolina at Chapel Hill ( Site 4026), Chapel Hill

28046

Hospital Universitario La Paz ( Site 5604), Madrid

30202

Hospital Santa Lucia ( Site 5603), Cartagena

30625

Medizinische Hochschule Hannover ( Site 4612), Hanover

31410

Chatham County Health Department ( Site 4029), Savannah

32803

Orlando Immunology Center ( Site 4012), Orlando

33075

CHU de Bordeaux- Hopital Saint Andre ( Site 4715), Bordeaux

33133

The Kinder Medical Group ( Site 4014), Miami

33407

Triple O Research Institute, P.A. ( Site 4020), West Palm Beach

34295

CHU de Montpellier - Hopital Saint-Eloi ( Site 4721), Montpellier

35222

University of Alabama at Birmingham 1917 Research Clinic ( Site 4031), Birmingham

39216

The University of Mississippi Medical Center ( Site 4036), Jackson

41124

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004), Modena

45122

Universitaetsklinikum Essen ( Site 4607), Essen

49115

Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619), Dnipro

49241

Pusan National University Hospital ( Site 5503), Busan

53127

Universitaetsklinikum Bonn ( Site 4600), Bonn

54003

Mykolaiv center of paliative assistance and integrated services ( Site 5621), Mykolayiv

59208

Centre Hospitalier de Tourcoing ( Site 4700), Tourcoing

60613

Howard Brown Health Center ( Site 4006), Chicago

60657

Northstar Healthcare ( Site 4004), Chicago

61096

Regional Clinical Infectious Hospital ( Site 5614), Kharkiv

65014

MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611), Odesa

69003

Hopital Edouard Herriot ( Site 4726), Lyon

73000

Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620), Kherson

75004

Hopital Hotel Dieu [Paris, France] ( Site 4723), Paris

75010

A.P.H. Paris, Hopital Saint Louis ( Site 4714), Paris

75018

A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724), Paris

75246

North Texas Infectious Diseases Consultants, PA ( Site 4005), Dallas

76031

CHU de Rouen ( Site 4705), Rouen

77401

Saint Hope Foundation, Inc. ( Site 4034), Bellaire

90069

Men's Health Foundation ( Site 4018), Los Angeles

92262

Palmtree Clinical Research, Inc. ( Site 4016), Palm Springs

93000

Hopital Avicenne ( Site 4702), Bobigny

98104

Dr. Peter Shalit, MD ( Site 4002), Seattle

105275

Infectious Clinical Hospital #2 ( Site 5114), Moscow

111321

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306), Bogotá

196645

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100), Saint Petersburg

214006

Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115), Smolensk

420140

Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104), Kazan'

443124

Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113), Samara

620102

Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106), Yekaterinburg

760032

Fundacion Valle del Lili ( Site 4301), Santiago de Cali

4781151

Hospital Dr. Hernan Henriquez Aravena ( Site 4405), Temuco

8360159

Fundacion Arriaran ( Site 4401), Santiago

8910259

Centro Cardiovascular Cardiosur ( Site 4407), Santiago

06510

Yale School of Medicine ( Site 4007), New Haven

07102

Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035), Newark

V6Z 2C7

Vancouver ID Research and Care Centre Society ( Site 4100), Vancouver

L8L 2X2

Hamilton Health Sciences ( Site 4115), Hamilton

K1H 8L6

Ottawa Hospital Research Institute ( Site 4111), Ottawa

M5G 2N2

Toronto General Hospital - University Health Network ( Site 4105), Toronto

H4A 3J1

McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102), Montreal

06202

CHU de Nice Hopital Archet 1 ( Site 4703), Nice

00149

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005), Roma

00168

Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006), Roma

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 5401), Tokyo

4835-044

Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905), Guimarães

2720-276

Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902), Amadora

1649-035

Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913), Lisbon

4099-001

Hospital Geral de Santo Antonio ( Site 4908), Porto

4200-319

Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907), Porto

00909

HOPE Clinical Research ( Site 5700), San Juan

Unknown

Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101), Saint Petersburg

03722

Severance Hospital Yonsei University Health System ( Site 5500), Seoul

06591

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502), Seoul

08916

Hospital Universitari Germans Trias i Pujol ( Site 5600), Badalona

08036

Hospital Clinic i Provincial ( Site 5601), Barcelona

03038

Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615), Kyiv

03115

Kyiv City Clinical Hospital 5 ( Site 5616), Kyiv

NW3 2QG

Royal Free Hospital ( Site 5202), London

EH4 2XU

Western General Hospital ( Site 5201), Edinburgh

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04233216 - Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) | Biotech Hunter | Biotech Hunter