A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

March 17, 2023

Primary Completion Date

December 3, 2025

Study Completion Date

September 6, 2028

Conditions
HIV Infection
Interventions
DRUG

DOR/ISL

FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

Trial Locations (95)

1211

Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804), Geneva

2010

Holdsworth House Medical Practice ( Site 1100), Darlinghurst

St Vincent's Hospital-IBAC ( Site 1103), Sydney

2013

Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605), Johannesburg

2092

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609), Johannesburg

2193

Ezintsha-Clinical Research Site ( Site 2607), Johannesburg

3010

Inselspital Bern-Inselspital Infektiologie ( Site 2803), Bern

3181

Prahran Market Clinic ( Site 1102), Melbourne

4006

Holdsworth House Medical Practice - Brisbane ( Site 1101), Brisbane

4052

Wentworth Hospital ( Site 2604), Durban

4056

University Hospital Basel-Infectiology ( Site 2802), Basel

6903

Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805), Lugano

7505

Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608), Cape Town

7646

Be Part Yoluntu Centre ( Site 2601), Paarl

7925

Desmond Tutu Health Foundation ( Site 2602), Cape Town

8011

Christchurch Hospital-Infectious Diseases ( Site 2200), Christchurch

8091

UniversitätsSpital Zürich ( Site 2800), Zurich

9007

Cantonal Hospital St.Gallen ( Site 2801), Sankt Gallen

9301

Josha Research ( Site 2603), Bloemfontein

10029

Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134), New York

19104

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

20007

Georgetown University Medical Center ( Site 3130), Washington D.C.

30033

Infectious Disease Specialists of Atlanta ( Site 3128), Decatur

30912

Augusta University-Infectious Diseases ( Site 3135), Augusta

31201

Mercer university, Department of internal medicine-Clinical Research ( Site 3129), Macon

31401

Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105), Savannah

32803

Orlando Immunology Center ( Site 3106), Orlando

32806

Bliss Healthcare Services ( Site 3115), Orlando

33016

Floridian Clinical Research, LLC ( Site 3133), Miami Lakes

33133

AHF The Kinder Medical Group ( Site 3108), Miami

33308

Therafirst Medical Center ( Site 3110), Fort Lauderdale

33407

Triple O Research Institute, P.A ( Site 3116), West Palm Beach

34237

CAN Community Health - Sarasota ( Site 3118), Sarasota

34982

Midway Immunology and Research Center ( Site 3117), Ft. Pierce

35222

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104), Birmingham

64111

KC CARE Health Center ( Site 3103), Kansas City

64239

Sourasky Medical Center ( Site 1904), Tel Aviv

75246

North Texas Infectious Diseases Consultants, P.A ( Site 3100), Dallas

75605

DCOL Center for Clinical Research ( Site 3119), Longview

76104

Texas Centers for Infectious Disease Associates ( Site 3111), Fort Worth

77098

The Crofoot Research Center ( Site 3101), Houston

77401

St Hope Foundation ( Site 3121), Bellaire

81362

Kaohsiung Veterans General Hospital ( Site 2901), Kaohsiung City

85015

Pueblo Family Physicians ( Site 3102), Phoenix

90027

Kaiser Permanente ( Site 3124), Los Angeles

90036

Ruane Clinical Research Group, Inc ( Site 3126), Los Angeles

90069

Mills Clinical Research ( Site 3114), Los Angeles

90211

Pacific Oaks Medical Group ( Site 3123), Beverly Hills

95817

University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137), Sacramento

98104

Private Practice - Dr. Peter Shalit ( Site 3120), Seattle

99202

Multicare Institute for Research and Innovation ( Site 3127), Spokane

105275

Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506), Moscow

110231

Hospital Universitario San Ignacio-Infectious ( Site 1501), Bogotá

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502), Bogotá

115035

Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502), Moscow

190020

Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact, Saint Petersburg

196645

Republican Clinical Infectious Hospital ( Site 2500), Saint Petersburg

420140

Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503), Kazan'

650056

Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505), Kemerovo

660049

Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504), Krasnoyarsk

760032

Fundación Valle del Lili ( Site 1500), Santiago de Cali

3109601

Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901), Haifa

3460000

Clinica Universidad Catolica del Maule ( Site 1405), Talca

4781151

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403), Temuco

5262100

Sheba Medical Center-HIV unit ( Site 1903), Ramat Gan

7500710

Biomedica Research Group-Infectology ( Site 1401), Santiago

8330034

Pontificia Universidad Catolica de Chile ( Site 1407), Santiago

8380420

Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400), Santiago

8910259

Cardio Sur ( Site 1409), Santiago

9112001

Hadassah Medical Center-Infecious Disease ( Site 1902), Jerusalem

08844

ID Care ( Site 3131), Hillsborough

X5000JJS

Instituto Oulton ( Site 1004), Córdoba

S2000PBJ

Instituto CAICI SRL ( Site 1003), Rosario

C1141ACG

Helios Salud ( Site 1002), Buenos Aires

C1202ABB

Fundación Huésped ( Site 1001), Buenos Aires

C1405CKC

Fundación IDEAA ( Site 1005), Buenos Aires

L8S 1A4

Hamilton Health Sciences- Urgent Care Centre ( Site 1304), Hamilton

M5G 1K2

Maple Leaf Research ( Site 1301), Toronto

M5G 2C4

Toronto General Hospital ( Site 1300), Toronto

H2L 4E9

Clinique de médecine Urbaine du Quartier Latin ( Site 1305), Montreal

H2L 4P9

Clinique Medicale lActuel ( Site 1303), Montreal

H4A 3J1

McGill University Health Centre ( Site 1306), Montreal

460-0001

National Hospital Organization Nagoya Medical Center ( Site 2103), Nagoya

113-8677

Tokyo Metropolitan Komagome Hospital ( Site 2105), Bunkyo

160-0023

Tokyo Medical University Hospital ( Site 2104), Shinjuku-ku

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 2101), Shinjyuku-ku

540-0006

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21, Osaka

00909

Clinical Research Puerto Rico ( Site 2400), San Juan

HOPE Clinical Research ( Site 2401), San Juan

0083

Private Practice Dr. Marleen de Jager ( Site 2600), Pretoria

BN2 1ES

University Hospitals Sussex NHS Foundation Trust ( Site 3004), East Sussex

BS10 5NB

Southmead Hospital ( Site 3003), Bristol

NW32QG

Royal Free Hospital ( Site 3002), London

SE5 9RL

King's College Hospital ( Site 3001), London

M8 5RB

North Manchester General Hospital ( Site 3005), Crumpsall

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05766501 - A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) | Biotech Hunter | Biotech Hunter