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)
NCT ID: NCT05766501
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
641 participants
INTERVENTIONAL
2023-03-17
2028-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DOR/ISL
Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.
DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Interventions
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DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
Birmingham, Alabama, United States
Pueblo Family Physicians ( Site 3102)
Phoenix, Arizona, United States
Pacific Oaks Medical Group ( Site 3123)
Beverly Hills, California, United States
Kaiser Permanente ( Site 3124)
Los Angeles, California, United States
Ruane Clinical Research Group, Inc ( Site 3126)
Los Angeles, California, United States
Mills Clinical Research ( Site 3114)
Los Angeles, California, United States
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
Sacramento, California, United States
Georgetown University Medical Center ( Site 3130)
Washington D.C., District of Columbia, United States
Therafirst Medical Center ( Site 3110)
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center ( Site 3117)
Ft. Pierce, Florida, United States
AHF The Kinder Medical Group ( Site 3108)
Miami, Florida, United States
Floridian Clinical Research, LLC ( Site 3133)
Miami Lakes, Florida, United States
Orlando Immunology Center ( Site 3106)
Orlando, Florida, United States
Bliss Healthcare Services ( Site 3115)
Orlando, Florida, United States
CAN Community Health - Sarasota ( Site 3118)
Sarasota, Florida, United States
Triple O Research Institute, P.A ( Site 3116)
West Palm Beach, Florida, United States
Augusta University-Infectious Diseases ( Site 3135)
Augusta, Georgia, United States
Infectious Disease Specialists of Atlanta ( Site 3128)
Decatur, Georgia, United States
Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
Macon, Georgia, United States
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
Savannah, Georgia, United States
KC CARE Health Center ( Site 3103)
Kansas City, Missouri, United States
ID Care ( Site 3131)
Hillsborough, New Jersey, United States
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
New York, New York, United States
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
Philadelphia, Pennsylvania, United States
St Hope Foundation ( Site 3121)
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, P.A ( Site 3100)
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates ( Site 3111)
Fort Worth, Texas, United States
The Crofoot Research Center ( Site 3101)
Houston, Texas, United States
DCOL Center for Clinical Research ( Site 3119)
Longview, Texas, United States
Private Practice - Dr. Peter Shalit ( Site 3120)
Seattle, Washington, United States
Multicare Institute for Research and Innovation ( Site 3127)
Spokane, Washington, United States
Instituto Oulton ( Site 1004)
Córdoba, Córdoba Province, Argentina
Instituto CAICI SRL ( Site 1003)
Rosario, Santa Fe Province, Argentina
Helios Salud ( Site 1002)
Buenos Aires, , Argentina
Fundación Huésped ( Site 1001)
Buenos Aires, , Argentina
Fundación IDEAA ( Site 1005)
Buenos Aires, , Argentina
Holdsworth House Medical Practice ( Site 1100)
Darlinghurst, New South Wales, Australia
St Vincent's Hospital-IBAC ( Site 1103)
Sydney, New South Wales, Australia
Holdsworth House Medical Practice - Brisbane ( Site 1101)
Brisbane, Queensland, Australia
Prahran Market Clinic ( Site 1102)
Melbourne, Victoria, Australia
Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
Hamilton, Ontario, Canada
Maple Leaf Research ( Site 1301)
Toronto, Ontario, Canada
Toronto General Hospital ( Site 1300)
Toronto, Ontario, Canada
Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
Montreal, Quebec, Canada
Clinique Medicale lActuel ( Site 1303)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 1306)
Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 1405)
Talca, Maule Region, Chile
Biomedica Research Group-Infectology ( Site 1401)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1407)
Santiago, Region M. de Santiago, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
Santiago, Region M. de Santiago, Chile
Cardio Sur ( Site 1409)
Santiago, Region M. de Santiago, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
Temuco, Región de la Araucanía, Chile
Hospital Universitario San Ignacio-Infectious ( Site 1501)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502)
Bogotá, Bogota D.C., Colombia
Fundación Valle del Lili ( Site 1500)
Cali, Valle del Cauca Department, Colombia
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
Haifa, , Israel
Hadassah Medical Center-Infecious Disease ( Site 1902)
Jerusalem, , Israel
Sheba Medical Center-HIV unit ( Site 1903)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 1904)
Tel Aviv, , Israel
National Hospital Organization Nagoya Medical Center ( Site 2103)
Nagoya, Aichi-ken, Japan
Tokyo Metropolitan Komagome Hospital ( Site 2105)
Bunkyo, Tokyo, Japan
Tokyo Medical University Hospital ( Site 2104)
Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
Shinjyuku-ku, Tokyo, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
Osaka, , Japan
Christchurch Hospital-Infectious Diseases ( Site 2200)
Christchurch, Canterbury, New Zealand
Clinical Research Puerto Rico ( Site 2400)
San Juan, , Puerto Rico
HOPE Clinical Research ( Site 2401)
San Juan, , Puerto Rico
Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
Kemerovo, Kemerovo Oblast, Russia
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Republican Clinical Infectious Hospital ( Site 2500)
Saint Petersburg, Leningradskaya Oblast', Russia
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
Moscow, Moscow, Russia
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
Moscow, Moscow, Russia
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
Kazan', Tatarstan, Respublika, Russia
Josha Research ( Site 2603)
Bloemfontein, Free State, South Africa
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
Johannesburg, Gauteng, South Africa
Ezintsha-Clinical Research Site ( Site 2607)
Johannesburg, Gauteng, South Africa
Private Practice Dr. Marleen de Jager ( Site 2600)
Pretoria, Gauteng, South Africa
Wentworth Hospital ( Site 2604)
Durban, KwaZulu-Natal, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation ( Site 2602)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 2601)
Paarl, Western Cape, South Africa
University Hospital Basel-Infectiology ( Site 2802)
Basel, Canton of Basel-City, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
Geneva, Canton of Geneva, Switzerland
Cantonal Hospital St.Gallen ( Site 2801)
Sankt Gallen, Canton of St. Gallen, Switzerland
UniversitätsSpital Zürich ( Site 2800)
Zurich, Canton of Zurich, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
Lugano, Canton Ticino, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 2803)
Bern, , Switzerland
Kaohsiung Veterans General Hospital ( Site 2901)
Kaohsiung City, , Taiwan
University Hospitals Sussex NHS Foundation Trust ( Site 3004)
East Sussex, Brighton And Hove, United Kingdom
Southmead Hospital ( Site 3003)
Bristol, Bristol, City of, United Kingdom
Royal Free Hospital ( Site 3002)
London, England, United Kingdom
King's College Hospital ( Site 3001)
London, London, City of, United Kingdom
North Manchester General Hospital ( Site 3005)
Crumpsall, Manchester, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-8591A-054
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502126-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2051230002
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1283-3863
Identifier Type: REGISTRY
Identifier Source: secondary_id
8591A-054
Identifier Type: -
Identifier Source: org_study_id