Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Last updated: September 12, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Hiv/aids

Aids And Aids Related Infections

Hiv Infections

Treatment

DOR/ISL

ART

Clinical Study ID

NCT04223778
8591A-017
MK-8591A-017
205165
2019-000586-20
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is HIV-1 positive

  • Has been receiving continuous, stable oral 2-drug or 3-drug combination (±pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50copies/mL) for ≥3 months prior to signing informed consent and has no history ofprior virologic treatment failure on any past or current regimen.

  • Female is eligible to participate if she is not pregnant or breastfeeding, and atleast one of the following conditions applies: is not a woman of childbearingpotential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or beabstinent from heterosexual intercourse as their preferred and usual lifestyle; aWOCBP must have a negative highly sensitive pregnancy test ([urine or serum] asrequired by local regulations) within 24 hours before the first dose of studyintervention; if a urine test cannot be confirmed as negative (e.g. an ambiguousresult), a serum pregnancy test is required. In such cases, the participant must beexcluded from participation if the serum pregnancy result is positive

Exclusion

Exclusion Criteria:

  • Has HIV-2 infection

  • Has hypersensitivity or other contraindication to any of the components of the studyinterventions as determined by the investigator

  • Has an active diagnosis of hepatitis due to any cause, including active Hepatitis BVirus (HBV) co-infection

  • Has a history of malignancy ≤5 years prior to signing informed consent except foradequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,or cutaneous Kaposi's sarcoma

  • Is taking or is anticipated to require systemic immunosuppressive therapy, immunemodulators, or any prohibited therapies

  • Is currently taking long-acting cabotegravir-rilpivirine

  • Is currently participating in or has participated in a clinical study with aninvestigational compound or device from 45 days prior to Day 1 through the studytreatment period

  • Has a documented or known virologic resistance to DOR

  • Female expects to conceive or donate eggs at any time during the study

Study Design

Total Participants: 672
Treatment Group(s): 2
Primary Treatment: DOR/ISL
Phase: 3
Study Start date:
February 18, 2020
Estimated Completion Date:
August 26, 2024

Connect with a study center

  • Holdsworth House Medical Practice ( Site 2300)

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Melbourne Sexual Health Centre ( Site 2305)

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Fiona Stanley Hospital ( Site 2301)

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Southern Alberta HIV Clinic ( Site 1108)

    Calgary, Alberta T2R 0X7
    Canada

    Site Not Available

  • Vancouver ID Research and Care Centre Society ( Site 1100)

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • Hamilton Health Sciences ( Site 1103)

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Maple Leaf Research ( Site 1112)

    Toronto, Ontario M5G 1K2
    Canada

    Site Not Available

  • Toronto General Hospital - University Health Network ( Site 1105)

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • Clinique Medicale L Actuel ( Site 1114)

    Montreal, Quebec H2L 4P9
    Canada

    Site Not Available

  • Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

    Montreal, Quebec H2L 4E9
    Canada

    Site Not Available

  • Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

    Temuco, Araucania 4781151
    Chile

    Site Not Available

  • Centro de Investigacion Clinica UC CICUC ( Site 1303)

    Santiago, Region Metropolitana De Santiago 8330034
    Chile

    Site Not Available

  • Clinica Arauco Salud ( Site 1300)

    Santiago, Region Metropolitana De Santiago 7560994
    Chile

    Site Not Available

  • Fundacion Valle del Lili ( Site 1201)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • Hopital Francois Mitterrand ( Site 2019)

    Dijon, Cote-d'Or 21079
    France

    Site Not Available

  • CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

    Bordeaux, Gironde 33075
    France

    Site Not Available

  • CHU de Toulouse - Hopital Purpan ( Site 2004)

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • CHU Hotel Dieu Nantes ( Site 2020)

    Nantes, Loire-Atlantique 44093
    France

    Site Not Available

  • Hopital de la Croix-Rousse ( Site 2027)

    Lyon, Rhone-Alpes 69317
    France

    Site Not Available

  • CHU de Rouen ( Site 2005)

    Rouen, Seine-Maritime 76031
    France

    Site Not Available

  • A.P.H. Paris, Hopital Saint Louis ( Site 2014)

    Paris, 75010
    France

    Site Not Available

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

    Milano, 20157
    Italy

    Site Not Available

  • A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

    Napoli, 80131
    Italy

    Site Not Available

  • Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

    Roma, 00168
    Italy

    Site Not Available

  • National Hospital Organization Nagoya Medical Center ( Site 2403)

    Nagoya, Aichi 460-0001
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital ( Site 2402)

    Osaka, 540-0006
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

    Tokyo, 162-8655
    Japan

    Site Not Available

  • Tokyo Medical University Hospital ( Site 2404)

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Tokyo Metropolitan Komagome Hospital ( Site 2406)

    Tokyo, 113-8677
    Japan

    Site Not Available

  • Christchurch Hospital ( Site 2303)

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

  • EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

    Wroclaw, Dolnoslaskie 50-220
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

    Lodz-Baluty, Lodzkie 91-347
    Poland

    Site Not Available

  • SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

    Warszawa, Mazowieckie 01-201
    Poland

    Site Not Available

  • Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

    Wroclaw, 50-136
    Poland

    Site Not Available

  • Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

    Kemerovo, Kemerovskaya Oblast' 650056
    Russian Federation

    Site Not Available

  • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

    Krasnoyarsk, Krasnoyarskiy Kray 660049
    Russian Federation

    Site Not Available

  • Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

    Saint Petersburg, Leningradskaya Oblast' 190020
    Russian Federation

    Site Not Available

  • Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

    Moscow, Moskva 105275
    Russian Federation

    Site Not Available

  • Infectious Clinical Hospital #2 ( Site 1719)

    Moscow, Moskva 105275
    Russian Federation

    Site Not Available

  • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

    Saint Petersburg, Sankt-Peterburg 196645
    Russian Federation

    Site Not Available

  • Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

    Yekaterinburg, Sverdlovskaya Oblast' 620102
    Russian Federation

    Site Not Available

  • Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

    Kazan, Tatarstan, Respublika 420140
    Russian Federation

    Site Not Available

  • JOSHA Research ( Site 1406)

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Hospital General de Elche ( Site 1608)

    Elche, Alicante 03202
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol ( Site 1606)

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Hospital Clinic i Provincial ( Site 1600)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon ( Site 1603)

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor ( Site 1601)

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 1604)

    Madrid, 28046
    Spain

    Site Not Available

  • Universitaetsspital Basel ( Site 3302)

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

  • Inselspital Universitaetsspital Bern ( Site 3303)

    Bern, Berne 3010
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve HUG. ( Site 3304)

    Geneva, Geneve 1211
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen ( Site 3301)

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Ospedale Regionale di Lugano Civico ( Site 3305)

    Lugano, Ticino 6903
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich ( Site 3300)

    Zuerich, Zurich 8091
    Switzerland

    Site Not Available

  • Brighton and Sussex University Hospital NHS Trust ( Site 1908)

    Brighton, Brighton And Hove BN2 1ES
    United Kingdom

    Site Not Available

  • Southmead Hospital ( Site 1910)

    Bristol, Bristol, City Of BS10 5NB
    United Kingdom

    Site Not Available

  • Royal Free Hospital ( Site 1904)

    London, Camden NW3 2QG
    United Kingdom

    Site Not Available

  • Kings College Hospital NHS Foundation Trust ( Site 1907)

    London, London, City Of SE5 9RJ
    United Kingdom

    Site Not Available

  • North Manchester General Hospital ( Site 1902)

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • Georgetown University Hospital ( Site 1018)

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Midway Immunology and Research ( Site 1030)

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Bliss Healthcare Services ( Site 1025)

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 1007)

    Orlando, Florida 32803
    United States

    Site Not Available

  • Triple O Research Institute, P.A. ( Site 1026)

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Chatham County Health Department ( Site 1043)

    Savannah, Georgia 31401
    United States

    Site Not Available

  • Northstar Healthcare ( Site 1002)

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Kansas City CARE Health Center ( Site 1008)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • ID Care ( Site 1023)

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill ( Site 1042)

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of Pennsylvania ( Site 1038)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Saint Hope Foundation, Inc. ( Site 1037)

    Bellaire, Texas 77401
    United States

    Site Not Available

  • North Texas ID Consultants, PA ( Site 1003)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • The Crofoot Research Center, Inc. ( Site 1005)

    Houston, Texas 77098
    United States

    Site Not Available

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