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)

Last updated: November 7, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Aids And Aids Related Infections

Hiv/aids

Treatment

DOR/ISL

Clinical Study ID

NCT05766501
8591A-054
MK-8591A-054
2022-502126-40-00
jRCT2051230002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

Exclusion

Exclusion Criteria:

  • Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-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-cellcounts or lymphocyte counts in the prior DOR/ISL study that meet criteria fordiscontinuation of DOR/ISL.

  • Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Study Design

Total Participants: 650
Treatment Group(s): 1
Primary Treatment: DOR/ISL
Phase: 3
Study Start date:
March 17, 2023
Estimated Completion Date:
September 06, 2028

Connect with a study center

  • Instituto Oulton ( Site 1004)

    Córdoba, Cordoba X5000JJS
    Argentina

    Site Not Available

  • Instituto CAICI SRL ( Site 1003)

    Rosario, Santa Fe S2000PBJ
    Argentina

    Site Not Available

  • Fundación Huésped ( Site 1001)

    Buenos Aires, C1202ABB
    Argentina

    Site Not Available

  • Fundación IDEAA ( Site 1005)

    Buenos Aires, C1405CKC
    Argentina

    Site Not Available

  • Helios Salud ( Site 1002)

    Buenos Aires, C1141ACG
    Argentina

    Site Not Available

  • Holdsworth House Medical Practice ( Site 1100)

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • St Vincent's Hospital-IBAC ( Site 1103)

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Holdsworth House Medical Practice - Brisbane ( Site 1101)

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • Prahran Market Clinic ( Site 1102)

    Melbourne, Victoria 3181
    Australia

    Site Not Available

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

    Hamilton, Ontario L8S 1A4
    Canada

    Site Not Available

  • Maple Leaf Research ( Site 1301)

    Toronto, Ontario M5G 1K2
    Canada

    Site Not Available

  • Toronto General Hospital ( Site 1300)

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Clinique de médecine Urbaine du Quartier Latin ( Site 1305)

    Montreal, Quebec H2L 4E9
    Canada

    Site Not Available

  • Clinique Medicale lActuel ( Site 1303)

    Montréal, Quebec H2L 4P9
    Canada

    Site Not Available

  • McGill University Health Centre ( Site 1306)

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

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

    Temuco, Araucania 4781151
    Chile

    Site Not Available

  • Clinica Universidad Catolica del Maule ( Site 1405)

    Talca, Maule 3460000
    Chile

    Site Not Available

  • Biomedica Research Group-Infectology ( Site 1401)

    Santiago, Region M. De Santiago 7500710
    Chile

    Site Not Available

  • Cardio Sur ( Site 1409)

    Santiago, Region M. De Santiago 8910259
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile ( Site 1407)

    Santiago, Region M. De Santiago 8330034
    Chile

    Site Not Available

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

    Santiago, Region M. De Santiago 8380420
    Chile

    Site Not Available

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

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio-Infectious ( Site 1501)

    Bogotá, Distrito Capital De Bogota 110231
    Colombia

    Site Not Available

  • Fundacion Valle del Lili- CIC ( Site 1500)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 1500)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

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

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center-Infecious Disease ( Site 1902)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Sheba Medical Center-HIV unit ( Site 1903)

    Ramat Gan, 5262100
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 1904)

    Tel Aviv, 64239
    Israel

    Site Not Available

  • National Hospital Organization Nagoya Medical Center ( Site 2103)

    Nagoya, Aichi 460-0001
    Japan

    Site Not Available

  • Tokyo Metropolitan Komagome Hospital ( Site 2105)

    Bunkyo, Tokyo 113-8677
    Japan

    Site Not Available

  • Tokyo Medical University Hospital ( Site 2104)

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine ( Site 2101)

    Shinjyuku-ku, Tokyo 162-8655
    Japan

    Site Not Available

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

    Osaka, 540-0006
    Japan

    Site Not Available

  • Christchurch Hospital-Infectious Diseases ( Site 2200)

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

  • Clinical Research Puerto Rico ( Site 2400)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • HOPE Clinical Research ( Site 2401)

    San Juan, 00909
    Puerto Rico

    Site Not Available

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

    Kemerovo, Kemerovskaya Oblast 650056
    Russian Federation

    Site Not Available

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

    Krasnoyarsk, Krasnoyarskiy Kray 660049
    Russian Federation

    Site Not Available

  • Republican Clinical Infectious Hospital ( Site 2500)

    Saint Petersburg, Leningradskaya Oblast 196645
    Russian Federation

    Site Not Available

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

    Moscow, Moskva 105275
    Russian Federation

    Site Not Available

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

    Moscow, Moskva 115035
    Russian Federation

    Site Not Available

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

    Saint Petersburg, Sankt-Peterburg 190020
    Russian Federation

    Site Not Available

  • Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)

    Kazan, Tatarstan, Respublika 420140
    Russian Federation

    Site Not Available

  • Josha Research ( Site 2603)

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Ezintsha-Clinical Research Site ( Site 2607)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

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

    Johannesburg, Gauteng 2092
    South Africa

    Site Not Available

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

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Private Practice Dr. Marleen de Jager ( Site 2600)

    Pretoria, Gauteng 0083
    South Africa

    Site Not Available

  • Wentworth Hospital ( Site 2604)

    Durban, Kwazulu-Natal 4052
    South Africa

    Site Not Available

  • Desmond Tutu Health Foundation ( Site 2602)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)

    Cape Town, Western Cape 7505
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre ( Site 2601)

    Paarl, Western Cape 7646
    South Africa

    Site Not Available

  • University Hospital Basel-Infectiology ( Site 2802)

    Basel, Basel-Stadt 4056
    Switzerland

    Site Not Available

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

    Genève, Geneve 1211
    Switzerland

    Site Not Available

  • Cantonal Hospital St.Gallen ( Site 2801)

    st.Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

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

    Lugano, Ticino 6903
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich ( Site 2800)

    Zürich, Zurich 8091
    Switzerland

    Site Not Available

  • Inselspital Bern-Inselspital Infektiologie ( Site 2803)

    Berne, 3010
    Switzerland

    Site Not Available

  • Kaohsiung Veterans General Hospital ( Site 2901)

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • University Hospitals Sussex NHS Foundation Trust ( Site 3004)

    East Sussex, Brighton And Hove BN2 1ES
    United Kingdom

    Site Not Available

  • Southmead Hospital ( Site 3003)

    Bristol, Bristol, City Of BS10 5NB
    United Kingdom

    Site Not Available

  • Royal Free Hospital ( Site 3002)

    London, England NW32QG
    United Kingdom

    Site Not Available

  • King's College Hospital ( Site 3001)

    London, London, City Of SE5 9RL
    United Kingdom

    Site Not Available

  • North Manchester General Hospital ( Site 3005)

    Crumpsall, Manchester M8 5RB
    United Kingdom

    Site Not Available

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

    Birmingham, Alabama 35222
    United States

    Site Not Available

  • Pueblo Family Physicians ( Site 3102)

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Pacific Oaks Medical Group ( Site 3123)

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Kaiser Permanente ( Site 3124)

    Los Angeles, California 90027
    United States

    Site Not Available

  • Mills Clinical Research ( Site 3114)

    Los Angeles, California 90069
    United States

    Site Not Available

  • Ruane Clinical Research Group, Inc ( Site 3126)

    Los Angeles, California 90036
    United States

    Site Not Available

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

    Sacramento, California 95817
    United States

    Site Not Available

  • Georgetown University Medical Center ( Site 3130)

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Therafirst Medical Center ( Site 3110)

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Midway Immunology and Research Center ( Site 3117)

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • AHF The Kinder Medical Group ( Site 3108)

    Miami, Florida 33133
    United States

    Site Not Available

  • Floridian Clinical Research, LLC ( Site 3133)

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Bliss Healthcare Services ( Site 3115)

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 3106)

    Orlando, Florida 32803
    United States

    Site Not Available

  • CAN Community Health - Sarasota ( Site 3118)

    Sarasota, Florida 34237
    United States

    Site Not Available

  • Triple O Research Institute, P.A ( Site 3116)

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Augusta University-Infectious Diseases ( Site 3135)

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Infectious Disease Specialists of Atlanta ( Site 3128)

    Decatur, Georgia 30033
    United States

    Site Not Available

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

    Macon, Georgia 31201
    United States

    Site Not Available

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

    Savannah, Georgia 31401
    United States

    Site Not Available

  • KC CARE Health Center ( Site 3103)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • ID Care ( Site 3131)

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

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

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • St Hope Foundation ( Site 3121)

    Bellaire, Texas 77401
    United States

    Site Not Available

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

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Centers for Infectious Disease Associates ( Site 3111)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • The Crofoot Research Center ( Site 3101)

    Houston, Texas 77098
    United States

    Site Not Available

  • DCOL Center for Clinical Research ( Site 3119)

    Longview, Texas 75605
    United States

    Site Not Available

  • Private Practice - Dr. Peter Shalit ( Site 3120)

    Seattle, Washington 98104
    United States

    Site Not Available

  • Multicare Institute for Research and Innovation ( Site 3127)

    Spokane, Washington 99202
    United States

    Site Not Available

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