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)
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
5 other identifiers
interventional
641
15 countries
95
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Longer than P75 for phase_3
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2028
ExpectedDecember 17, 2025
December 1, 2025
2.6 years
March 1, 2023
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with One or More Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented.
Up to 96 Weeks
Percentage of participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.
Up to 96 Weeks
Secondary Outcomes (4)
Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96
Week 96
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
Week 96
Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96
Week 96
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Up to Week 96
Study Arms (1)
DOR/ISL
EXPERIMENTALParticipants 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.
Interventions
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Eligibility Criteria
You may qualify if:
- Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).
You may not qualify if:
- Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
Birmingham, Alabama, 35222, United States
Pueblo Family Physicians ( Site 3102)
Phoenix, Arizona, 85015, United States
Pacific Oaks Medical Group ( Site 3123)
Beverly Hills, California, 90211, United States
Kaiser Permanente ( Site 3124)
Los Angeles, California, 90027, United States
Ruane Clinical Research Group, Inc ( Site 3126)
Los Angeles, California, 90036, United States
Mills Clinical Research ( Site 3114)
Los Angeles, California, 90069, United States
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
Sacramento, California, 95817, United States
Georgetown University Medical Center ( Site 3130)
Washington D.C., District of Columbia, 20007, United States
Therafirst Medical Center ( Site 3110)
Fort Lauderdale, Florida, 33308, United States
Midway Immunology and Research Center ( Site 3117)
Ft. Pierce, Florida, 34982, United States
AHF The Kinder Medical Group ( Site 3108)
Miami, Florida, 33133, United States
Floridian Clinical Research, LLC ( Site 3133)
Miami Lakes, Florida, 33016, United States
Orlando Immunology Center ( Site 3106)
Orlando, Florida, 32803, United States
Bliss Healthcare Services ( Site 3115)
Orlando, Florida, 32806, United States
CAN Community Health - Sarasota ( Site 3118)
Sarasota, Florida, 34237, United States
Triple O Research Institute, P.A ( Site 3116)
West Palm Beach, Florida, 33407, United States
Augusta University-Infectious Diseases ( Site 3135)
Augusta, Georgia, 30912, United States
Infectious Disease Specialists of Atlanta ( Site 3128)
Decatur, Georgia, 30033, United States
Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
Macon, Georgia, 31201, United States
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
Savannah, Georgia, 31401, United States
KC CARE Health Center ( Site 3103)
Kansas City, Missouri, 64111, United States
ID Care ( Site 3131)
Hillsborough, New Jersey, 08844, United States
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
New York, New York, 10029, United States
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
Philadelphia, Pennsylvania, 19104, United States
St Hope Foundation ( Site 3121)
Bellaire, Texas, 77401, United States
North Texas Infectious Diseases Consultants, P.A ( Site 3100)
Dallas, Texas, 75246, United States
Texas Centers for Infectious Disease Associates ( Site 3111)
Fort Worth, Texas, 76104, United States
The Crofoot Research Center ( Site 3101)
Houston, Texas, 77098, United States
DCOL Center for Clinical Research ( Site 3119)
Longview, Texas, 75605, United States
Private Practice - Dr. Peter Shalit ( Site 3120)
Seattle, Washington, 98104, United States
Multicare Institute for Research and Innovation ( Site 3127)
Spokane, Washington, 99202, United States
Instituto Oulton ( Site 1004)
Córdoba, Córdoba Province, X5000JJS, Argentina
Instituto CAICI SRL ( Site 1003)
Rosario, Santa Fe Province, S2000PBJ, Argentina
Helios Salud ( Site 1002)
Buenos Aires, C1141ACG, Argentina
Fundación Huésped ( Site 1001)
Buenos Aires, C1202ABB, Argentina
Fundación IDEAA ( Site 1005)
Buenos Aires, C1405CKC, Argentina
Holdsworth House Medical Practice ( Site 1100)
Darlinghurst, New South Wales, 2010, Australia
St Vincent's Hospital-IBAC ( Site 1103)
Sydney, New South Wales, 2010, Australia
Holdsworth House Medical Practice - Brisbane ( Site 1101)
Brisbane, Queensland, 4006, Australia
Prahran Market Clinic ( Site 1102)
Melbourne, Victoria, 3181, Australia
Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
Hamilton, Ontario, L8S 1A4, Canada
Maple Leaf Research ( Site 1301)
Toronto, Ontario, M5G 1K2, Canada
Toronto General Hospital ( Site 1300)
Toronto, Ontario, M5G 2C4, Canada
Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
Montreal, Quebec, H2L 4E9, Canada
Clinique Medicale lActuel ( Site 1303)
Montreal, Quebec, H2L 4P9, Canada
McGill University Health Centre ( Site 1306)
Montreal, Quebec, H4A 3J1, Canada
Clinica Universidad Catolica del Maule ( Site 1405)
Talca, Maule Region, 3460000, Chile
Biomedica Research Group-Infectology ( Site 1401)
Santiago, Region M. de Santiago, 7500710, Chile
Pontificia Universidad Catolica de Chile ( Site 1407)
Santiago, Region M. de Santiago, 8330034, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
Santiago, Region M. de Santiago, 8380420, Chile
Cardio Sur ( Site 1409)
Santiago, Region M. de Santiago, 8910259, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
Temuco, Región de la Araucanía, 4781151, Chile
Hospital Universitario San Ignacio-Infectious ( Site 1501)
Bogotá, Bogota D.C., 110231, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502)
Bogotá, Bogota D.C., 111321, Colombia
Fundación Valle del Lili ( Site 1500)
Cali, Valle del Cauca Department, 760032, Colombia
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
Haifa, 3109601, Israel
Hadassah Medical Center-Infecious Disease ( Site 1902)
Jerusalem, 9112001, Israel
Sheba Medical Center-HIV unit ( Site 1903)
Ramat Gan, 5262100, Israel
Sourasky Medical Center ( Site 1904)
Tel Aviv, 64239, Israel
National Hospital Organization Nagoya Medical Center ( Site 2103)
Nagoya, Aichi-ken, 460-0001, Japan
Tokyo Metropolitan Komagome Hospital ( Site 2105)
Bunkyo, Tokyo, 113-8677, Japan
Tokyo Medical University Hospital ( Site 2104)
Shinjuku-ku, Tokyo, 160-0023, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
Shinjyuku-ku, Tokyo, 162-8655, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
Osaka, 540-0006, Japan
Christchurch Hospital-Infectious Diseases ( Site 2200)
Christchurch, Canterbury, 8011, New Zealand
Clinical Research Puerto Rico ( Site 2400)
San Juan, 00909, Puerto Rico
HOPE Clinical Research ( Site 2401)
San Juan, 00909, Puerto Rico
Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
Kemerovo, Kemerovo Oblast, 650056, Russia
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
Krasnoyarsk, Krasnoyarsk Krai, 660049, Russia
Republican Clinical Infectious Hospital ( Site 2500)
Saint Petersburg, Leningradskaya Oblast', 196645, Russia
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
Moscow, Moscow, 105275, Russia
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
Moscow, Moscow, 115035, Russia
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
Saint Petersburg, Sankt-Peterburg, 190020, Russia
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
Kazan', Tatarstan, Respublika, 420140, Russia
Josha Research ( Site 2603)
Bloemfontein, Free State, 9301, South Africa
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
Johannesburg, Gauteng, 2013, South Africa
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
Johannesburg, Gauteng, 2092, South Africa
Ezintsha-Clinical Research Site ( Site 2607)
Johannesburg, Gauteng, 2193, South Africa
Private Practice Dr. Marleen de Jager ( Site 2600)
Pretoria, Gauteng, 0083, South Africa
Wentworth Hospital ( Site 2604)
Durban, KwaZulu-Natal, 4052, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
Cape Town, Western Cape, 7505, South Africa
Desmond Tutu Health Foundation ( Site 2602)
Cape Town, Western Cape, 7925, South Africa
Be Part Yoluntu Centre ( Site 2601)
Paarl, Western Cape, 7646, South Africa
University Hospital Basel-Infectiology ( Site 2802)
Basel, Canton of Basel-City, 4056, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
Geneva, Canton of Geneva, 1211, Switzerland
Cantonal Hospital St.Gallen ( Site 2801)
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
UniversitätsSpital Zürich ( Site 2800)
Zurich, Canton of Zurich, 8091, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
Lugano, Canton Ticino, 6903, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 2803)
Bern, 3010, Switzerland
Kaohsiung Veterans General Hospital ( Site 2901)
Kaohsiung City, 81362, Taiwan
University Hospitals Sussex NHS Foundation Trust ( Site 3004)
East Sussex, Brighton And Hove, BN2 1ES, United Kingdom
Southmead Hospital ( Site 3003)
Bristol, Bristol, City of, BS10 5NB, United Kingdom
Royal Free Hospital ( Site 3002)
London, England, NW32QG, United Kingdom
King's College Hospital ( Site 3001)
London, London, City of, SE5 9RL, United Kingdom
North Manchester General Hospital ( Site 3005)
Crumpsall, Manchester, M8 5RB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
March 17, 2023
Primary Completion
October 16, 2025
Study Completion (Estimated)
September 6, 2028
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf