A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

553

Participants

Timeline

Start Date

February 20, 2023

Primary Completion Date

October 10, 2024

Study Completion Date

July 11, 2028

Conditions
HIV-1 Infection
Interventions
DRUG

ART

Standard of care ART, per approved product list, taken orally

DRUG

DOR/ISL

Combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.

Trial Locations (53)

1011

CHUV (centre hospitalier universitaire vaudois) ( Site 4006), Lausanne

1211

Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4004), Geneva

2010

Holdsworth House Medical Practice ( Site 4200), Darlinghurst

St Vincent's Hospital-IBAC ( Site 4203), Sydney

2013

Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905), Johannesburg

2092

Helen Joseph Hospital ( Site 3910), Johannesburg

2193

Ezintsha-Clinical Research Site ( Site 3907), Johannesburg

3010

Inselspital Bern-Inselspital Infektiologie ( Site 4003), Bern

3181

Prahran Market Clinic ( Site 4202), Melbourne

4006

Holdsworth House Medical Practice - Brisbane ( Site 4201), Brisbane

4029

Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204), Brisbane

4031

University Hospital Basel-Infectiology ( Site 4002), Basel

4052

Wentworth Hospital ( Site 3904), Durban

6903

Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4005), Lugano

7505

Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908), Cape Town

7646

Be Part Yoluntu Centre ( Site 3901), Paarl

7925

Desmond Tutu Health Foundation ( Site 3902), Cape Town

8091

UniversitätsSpital Zürich ( Site 4000), Zurich

9300

Josha Research ( Site 3903), Bloemfontein

19104

Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site, Philadelphia

20007

Georgetown University Medical Center ( Site 3006), Washington D.C.

30033

Infectious Disease Specialists of Atlanta ( Site 3003), Decatur

31401

Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028), Savannah

32803

Orlando Immunology Center ( Site 3004), Orlando

33407

Triple O Research Institute, P.A ( Site 3026), West Palm Beach

34237

CAN Community Health - Sarasota ( Site 3017), Sarasota

34982

Midway Immunology and Research Center ( Site 3009), Ft. Pierce

75605

DCOL Center for Clinical Research ( Site 3022), Longview

77098

The Crofoot Research Center ( Site 3040), Houston

78705

Central Texas Clinical Research ( Site 3015), Austin

90027

Kaiser Permanente-Infectious Disease ( Site 3014), Los Angeles

92262

Palmtree Clinical Research ( Site 3032), Palm Springs

94110

Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30, San Francisco

760032

Fundacion Valle del Lili- CIC ( Site 3302), Santiago de Cali

08844

ID Care ( Site 3041), Hillsborough

L8S 1A4

Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104), Hamilton

M5G 1K2

Maple Leaf Research ( Site 3103), Toronto

M5G 2M1

Toronto General Hospital ( Site 3102), Toronto

H2L 4E9

Clinique de médecine Urbaine du Quartier Latin ( Site 3101), Montreal

H2L 4P9

Clinique Medicale lActuel-Clinical Research ( Site 3100), Montreal

08001

Ciensalud Ips S A S ( Site 3300), Barranquilla

080020

Clinica de la Costa S.A.S. ( Site 3305), Barranquilla

460-0001

National Hospital Organization Nagoya Medical Center ( Site 4403), Nagoya

160-0023

Tokyo Medical University Hospital ( Site 4404), Shinjuku-ku

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 4401), Shinjyuku-ku

0007

Private Practice Dr. Marleen de Jager ( Site 3900), Pretoria

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust ( Site 4104), East Sussex

M8 5RB

North Manchester General Hospital ( Site 4107), Crumpsall

E1 1BB

Royal London Hospital ( Site 4100), London

NW32QG

Royal Free Hospital ( Site 4101), London

NE1 4LP

Royal Victoria Infirmary ( Site 4105), Newcastle upon Tyne

SE5 9RL

King's College Hospital ( Site 4108), London

B9 5SS

Heartlands Hospital ( Site 4102), Birmingham

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY