Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

PHASE3CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

February 18, 2020

Primary Completion Date

August 26, 2021

Study Completion Date

February 27, 2025

Conditions
HIV Infection
Interventions
DRUG

DOR/ISL

100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily

DRUG

BIC/FTC/TAF

50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily

DRUG

Placebo to BIC/FTC/TAF

Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily

DRUG

Placebo to FDC DOR/ISL

Placebo to FDC DOR/ISL in a tablet taken orally, once daily

Trial Locations (89)

1090

Medical University Vienna ( Site 3402), Vienna

1100

Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400), Vienna

1145

Social Medical Center - Otto Wagner Hospital ( Site 3404), Vienna

2010

St Vincent's Hospital ( Site 3807), Darlinghurst

Taylor Square Private Clinic ( Site 3804), Darlinghurst

Holdsworth House Medical Practice ( Site 3800), Sydney

3004

The Alfred Hospital ( Site 3802), Melbourne

3181

Prahran Market Clinic (PMC) ( Site 3806), Melbourne

4006

Holdsworth House Medical Practice - Brisbane ( Site 3810), Brisbane

4029

Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812), Herston

8020

LKH Graz West ( Site 3401), Graz

10029

Icahn School of Medicine at Mount Sinai ( Site 2700), New York

10439

ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003), Berlin

10467

Montefiore Einstein Center ( Site 2730), The Bronx

12167

EPIMED GmbH ( Site 3008), Berlin

13003

Hopital Europeen Marseille ( Site 3117), Marseille

20009

Whitman-Walker Clinic ( Site 2728), Washington D.C.

20122

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501), Milan

20127

Universita' Vita Salute. Ospedale San Raffaele ( Site 3502), Milan

20142

Azienda Ospedaliera San Paolo ( Site 3503), Milan

20146

ICH Study Center GmbH & Co.KG ( Site 3009), Hamburg

20157

ASST Fatebenefratelli-Ospedale Sacco ( Site 3500), Milan

20246

Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010), Hamburg

28007

Hospital General Universitario Gregorio Maranon ( Site 3603), Madrid

28031

Hospital Universitario Infanta Leonor ( Site 3606), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 3611), Madrid

28041

Hospital 12 de Octubre de Madrid ( Site 3605), Madrid

28046

Hospital Universitario La Paz ( Site 3604), Madrid

29010

Hospital Universitario Virgen de la Victoria ( Site 3609), Málaga

30033

Infectious Disease Specialists Of Atlanta PC ( Site 2719), Decatur

30625

Medizinische Hochschule Hannover ( Site 3012), Hanover

30912

Augusta University ( Site 2752), Augusta

31201

Mercer University ( Site 2738), Macon

31401

Chatham County Health Department ( Site 2731), Savannah

32803

Orlando Immunology Center ( Site 2734), Orlando

33133

The Kinder Medical Group ( Site 2739), Miami

33140

AHF South Beach ( Site 2780), Miami Beach

33308

TheraFirst Medical Center ( Site 2742), Fort Lauderdale

33407

Triple O Research Institute, P.A. ( Site 2755), West Palm Beach

34295

CHU de Montpellier - Hopital Saint-Eloi ( Site 3121), Montpellier

34982

Midway Immunology and Research ( Site 2759), Ft. Pierce

44093

CHU Hotel Dieu Nantes ( Site 3120), Nantes

45000

Centre Hospitalier Regional du Orleans ( Site 3108), Orléans

45122

Universitaetsklinikum Essen ( Site 3007), Essen

53127

Universitaetsklinikum Bonn ( Site 3000), Bonn

54511

CHU de Nancy Hopital Brabois Adultes ( Site 3128), Vandœuvre-lès-Nancy

55415

Hennepin County Medical Center ( Site 2733), Minneapolis

59208

Centre Hospitalier de Tourcoing ( Site 3100), Tourcoing

60596

Infektiologikum ( Site 3001), Frankfurt am Main

64111

Kansas City CARE Clinic ( Site 2718), Kansas City

69003

Hopital Edouard Herriot ( Site 3126), Lyon

75012

Hopital Saint-Antoine ( Site 3113), Paris

75013

Hopital Pitie Salpetriere ( Site 3111), Paris

75020

Hopital Tenon ( Site 3118), Paris

75246

North Texas ID Consultants, PA ( Site 2707), Dallas

75605

DCOL Center for Clinical Research ( Site 2769), Longview

77098

The Crofoot Research Center, Inc. ( Site 2715), Houston

80069

Men's Health Foundation ( Site 2749), Los Angeles

80131

A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507), Napoli

80335

MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002), Munich

80336

Klinikum der LMU München ( Site 3004), Munich

81675

Klinikum rechts der Isar der Technischen Universitat ( Site 3005), Munich

85015

Pueblo Family Physicians ( Site 2717), Phoenix

90027

Kaiser Permanente Los Angeles Medical Center ( Site 2775), Los Angeles

90211

Pacific Oaks Medical Group ( Site 2765), Beverly Hills

92151

Hopital Foch ( Site 3129), Suresnes

92264

Eisenhower Medical Center ( Site 2744), Palm Springs

94110

Zuckerberg San Francisco General Hospital UCSF ( Site 2743), San Francisco

95811

University of California, Davis, Division of ID Research ( Site 2702), Sacramento

98104

Dr. Peter Shalit, MD ( Site 2770), Seattle

99204

Multicare Health System ( Site 2713), Spokane

08844

ID Care ( Site 2751), Hillsborough

V6Z 2C7

Vancouver ID Research and Care Centre Society ( Site 2800), Vancouver

L8L 2X2

Hamilton Health Sciences ( Site 2803), Hamilton

H2L 4E9

Clinique de Medecine Urbaine du Quartier Latin ( Site 2804), Montreal

H2L 4P9

Clinique Medicale L Actuel ( Site 2814), Montreal

00029

Helsinki University Hospital ( Site 3200), Helsinki

06202

CHU de Nice Hopital Archet 1 ( Site 3103), Nice

460-0001

National Hospital Organization Nagoya Medical Center ( Site 7203), Nagoya

540-0006

National Hospital Organization Osaka National Hospital ( Site 7202), Osaka

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 7201), Tokyo

00716

CAIMED Center - Ponce School of Medicine ( Site 2903), Ponce

00925

Puerto Rico CONCRA ( Site 2904), Rio Piedras

00909

Clinical Research Puerto Rico Inc ( Site 2900), San Juan

Hope Clinical Research, Inc. ( Site 2902), San Juan

08916

Hospital Universitari Germans Trias i Pujol ( Site 3601), Badalona

08035

Hospital Universitari Vall d Hebron ( Site 3602), Barcelona

08907

Hospital Universitari de Bellvitge ( Site 3612), LHospitalet de Llobregat

08036

Hospital Clinic i Provincial ( Site 3600), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04223791 - Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) | Biotech Hunter | Biotech Hunter