Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
NCT ID: NCT04223778
Last Updated: 2026-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
672 participants
INTERVENTIONAL
2020-02-18
2024-08-26
Brief Summary
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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)
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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Doravirine/Islatravir (DOR/ISL)
Participants who were previously treated with continuous baseline antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.
DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Group 2: Baseline Antiretroviral Therapy (ART)
Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
ART
Baseline ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Interventions
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DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
ART
Baseline ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
* Females are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
Exclusion Criteria
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately 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, immune modulators, or any prohibited therapies
* Is currently taking long-acting cabotegravir-rilpivirine
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virologic resistance to doravirine (DOR)
* Expects to conceive or donate eggs at any time during the study
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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Georgetown University Hospital ( Site 1018)
Washington D.C., District of Columbia, United States
Midway Immunology and Research ( Site 1030)
Ft. Pierce, Florida, United States
Orlando Immunology Center ( Site 1007)
Orlando, Florida, United States
Bliss Healthcare Services ( Site 1025)
Orlando, Florida, United States
Triple O Research Institute, P.A. ( Site 1026)
West Palm Beach, Florida, United States
Chatham County Health Department ( Site 1043)
Savannah, Georgia, United States
Northstar Healthcare ( Site 1002)
Chicago, Illinois, United States
Kansas City CARE Health Center ( Site 1008)
Kansas City, Missouri, United States
ID Care ( Site 1023)
Hillsborough, New Jersey, United States
University of North Carolina at Chapel Hill ( Site 1042)
Chapel Hill, North Carolina, United States
University of Pennsylvania ( Site 1038)
Philadelphia, Pennsylvania, United States
Saint Hope Foundation, Inc. ( Site 1037)
Bellaire, Texas, United States
North Texas ID Consultants, PA ( Site 1003)
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates P.A. ( Site 1022)
Fort Worth, Texas, United States
The Crofoot Research Center, Inc. ( Site 1005)
Houston, Texas, United States
Holdsworth House Medical Practice ( Site 2300)
Sydney, New South Wales, Australia
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)
Herston, Queensland, Australia
Melbourne Sexual Health Centre ( Site 2305)
Carlton, Victoria, Australia
Fiona Stanley Hospital ( Site 2301)
Murdoch, Western Australia, Australia
Southern Alberta HIV Clinic ( Site 1108)
Calgary, Alberta, Canada
Vancouver ID Research and Care Centre Society ( Site 1100)
Vancouver, British Columbia, Canada
Hamilton Health Sciences ( Site 1103)
Hamilton, Ontario, Canada
Maple Leaf Research ( Site 1112)
Toronto, Ontario, Canada
Toronto General Hospital - University Health Network ( Site 1105)
Toronto, Ontario, Canada
Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)
Montreal, Quebec, Canada
Clinique Medicale L Actuel ( Site 1114)
Montreal, Quebec, Canada
Hospital Dr. Hernan Henriquez Aravena ( Site 1305)
Temuco, Región de la Araucanía, Chile
Clinica Arauco Salud ( Site 1300)
Santiago, Santiago Metropolitan, Chile
Centro de Investigacion Clinica UC CICUC ( Site 1303)
Santiago, Santiago Metropolitan, Chile
Fundacion Valle del Lili ( Site 1201)
Cali, Valle del Cauca Department, Colombia
Hopital de la Croix-Rousse ( Site 2027)
Lyon, Auvergne-Rhône-Alpes, France
Hopital Francois Mitterrand ( Site 2019)
Dijon, Cote-d'Or, France
CHU de Bordeaux- Hopital Saint Andre ( Site 2015)
Bordeaux, Gironde, France
CHU de Toulouse - Hopital Purpan ( Site 2004)
Toulouse, Haute-Garonne, France
CHU Hotel Dieu Nantes ( Site 2020)
Nantes, Loire-Atlantique, France
CHU de Rouen ( Site 2005)
Rouen, Seine-Maritime, France
A.P.H. Paris, Hopital Saint Louis ( Site 2014)
Paris, , France
ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)
Milan, , Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)
Napoli, , Italy
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)
Roma, , Italy
National Hospital Organization Nagoya Medical Center ( Site 2403)
Nagoya, Aichi-ken, Japan
National Hospital Organization Osaka National Hospital ( Site 2402)
Osaka, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 2406)
Tokyo, , Japan
Tokyo Medical University Hospital ( Site 2404)
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 2401)
Tokyo, , Japan
Christchurch Hospital ( Site 2303)
Christchurch, Canterbury, New Zealand
EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)
Wroclaw, Lower Silesian Voivodeship, Poland
SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)
Warsaw, Masovian Voivodeship, Poland
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)
Wroclaw, , Poland
Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)
Lodz-Baluty, Łódź Voivodeship, Poland
Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)
Kemerovo, Kemerovo Oblast, Russia
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)
Saint Petersburg, Leningradskaya Oblast', Russia
Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)
Moscow, Moscow, Russia
Infectious Clinical Hospital #2 ( Site 1719)
Moscow, Moscow, Russia
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)
Saint Petersburg, Sankt-Peterburg, Russia
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)
Kazan', Tatarstan, Respublika, Russia
JOSHA Research ( Site 1406)
Bloemfontein, Free State, South Africa
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)
Cape Town, Western Cape, South Africa
Hospital General de Elche ( Site 1608)
Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol ( Site 1606)
Badalona, Barcelona [Barcelona], Spain
Hospital Clinic i Provincial ( Site 1600)
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 1603)
Madrid, , Spain
Hospital Universitario Infanta Leonor ( Site 1601)
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1604)
Madrid, , Spain
Universitaetsspital Basel ( Site 3302)
Basel, Canton of Basel-City, Switzerland
Inselspital Universitaetsspital Bern ( Site 3303)
Bern, Canton of Bern, Switzerland
Hopitaux Universitaires de Geneve HUG. ( Site 3304)
Geneva, Canton of Geneva, Switzerland
Kantonsspital St. Gallen ( Site 3301)
Sankt Gallen, Canton of St. Gallen, Switzerland
Universitaetsspital Zuerich ( Site 3300)
Zurich, Canton of Zurich, Switzerland
Ospedale Regionale di Lugano Civico ( Site 3305)
Lugano, Canton Ticino, Switzerland
Brighton and Sussex University Hospital NHS Trust ( Site 1908)
Brighton, Brighton And Hove, United Kingdom
Southmead Hospital ( Site 1910)
Bristol, Bristol, City of, United Kingdom
Royal Free Hospital ( Site 1904)
London, Camden, United Kingdom
Kings College Hospital NHS Foundation Trust ( Site 1907)
London, London, City of, United Kingdom
North Manchester General Hospital ( Site 1902)
Manchester, , United Kingdom
Countries
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References
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Molina JM, Rizzardini G, Orrell C, Afani A, Calmy A, Oka S, Hinestrosa F, Kumar P, Tebas P, Walmsley S, Grandhi A, Klopfer S, Gendrano I, Eves K, Correll TA, Fox MC, Kim J. Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial. Lancet HIV. 2024 Jun;11(6):e369-e379. doi: 10.1016/S2352-3018(24)00031-6. Epub 2024 May 8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-8591A-017
Identifier Type: OTHER
Identifier Source: secondary_id
205165
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-000586-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591A-017
Identifier Type: -
Identifier Source: org_study_id
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