Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
NCT ID: NCT04233216
Last Updated: 2024-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2020-03-18
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ISL + ART
HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.
ISL
ISL 0.75 mg capsule taken by mouth.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
DOR + ART
HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
DOR
DOR 100 mg tablet taken by mouth.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
DOR/ISL + ART
HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Placebo + ART
HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Placebo to DOR
Placebo tablet matched to DOR taken by mouth.
Interventions
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ISL
ISL 0.75 mg capsule taken by mouth.
DOR
DOR 100 mg tablet taken by mouth.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Placebo to DOR
Placebo tablet matched to DOR taken by mouth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form.
* Weighs ≥35 kg.
* Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor \[NRTI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor (InSTI), based on central laboratory-based resistance or proviral DNA resistance testing at the Screening Visit, or historical resistance testing within 12 months of screening.
* Has ≤2 fully active antiretroviral drugs remaining among all antiretroviral classes that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant.
* If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication.
Exclusion Criteria
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
* Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive) and is not currently being treated for HBV.
* Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration.
* Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period.
* Is taking DOR as part of his/her current failing antiretroviral regimen.
* Is taking efavirenz (EFV), etravirine, or nevirapine.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period.
* Is female and is expecting to conceive or donate eggs at any time during the study.
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 1917 Research Clinic ( Site 4031)
Birmingham, Alabama, United States
Men's Health Foundation ( Site 4018)
Los Angeles, California, United States
Palmtree Clinical Research, Inc. ( Site 4016)
Palm Springs, California, United States
Yale School of Medicine ( Site 4007)
New Haven, Connecticut, United States
Georgetown University Hospital ( Site 4015)
Washington D.C., District of Columbia, United States
The Kinder Medical Group ( Site 4014)
Miami, Florida, United States
Orlando Immunology Center ( Site 4012)
Orlando, Florida, United States
Triple O Research Institute, P.A. ( Site 4020)
West Palm Beach, Florida, United States
Chatham County Health Department ( Site 4029)
Savannah, Georgia, United States
Howard Brown Health Center ( Site 4006)
Chicago, Illinois, United States
Northstar Healthcare ( Site 4004)
Chicago, Illinois, United States
University of Maryland ( Site 4023)
Baltimore, Maryland, United States
The University of Mississippi Medical Center ( Site 4036)
Jackson, Mississippi, United States
Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)
Newark, New Jersey, United States
Icahn School of Medicine at Mount Sinai ( Site 4000)
New York, New York, United States
University of North Carolina at Chapel Hill ( Site 4026)
Chapel Hill, North Carolina, United States
Saint Hope Foundation, Inc. ( Site 4034)
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, PA ( Site 4005)
Dallas, Texas, United States
Dr. Peter Shalit, MD ( Site 4002)
Seattle, Washington, United States
Holdsworth House Medical Practice ( Site 5300)
Sydney, New South Wales, Australia
St Vincent's Hospital ( Site 5309)
Sydney, New South Wales, Australia
Holdsworth House Medical Practice - Brisbane ( Site 5312)
Brisbane, Queensland, Australia
Monash Health-Monash Medical Centre ( Site 5313)
Clayton, Victoria, Australia
The Alfred Hospital ( Site 5304)
Melbourne, Victoria, Australia
Vancouver ID Research and Care Centre Society ( Site 4100)
Vancouver, British Columbia, Canada
Hamilton Health Sciences ( Site 4115)
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute ( Site 4111)
Ottawa, Ontario, Canada
Toronto General Hospital - University Health Network ( Site 4105)
Toronto, Ontario, Canada
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)
Montreal, Quebec, Canada
Fundacion Arriaran ( Site 4401)
Santiago, Region M. de Santiago, Chile
Centro Cardiovascular Cardiosur ( Site 4407)
Santiago, Region M. de Santiago, Chile
Hospital Dr. Hernan Henriquez Aravena ( Site 4405)
Temuco, Región de la Araucanía, Chile
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili ( Site 4301)
Cali, Valle del Cauca Department, Colombia
Hopital Edouard Herriot ( Site 4726)
Lyon, Ain, France
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)
Paris, Ain, France
CHU de Nice Hopital Archet 1 ( Site 4703)
Nice, Alpes-Maritimes, France
Hopital Europeen Marseille ( Site 4717)
Marseille, Bouches-du-Rhone, France
CHU de Bordeaux- Hopital Saint Andre ( Site 4715)
Bordeaux, Gironde, France
CHU de Rouen ( Site 4705)
Rouen, Haute-Normandie, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)
Montpellier, Herault, France
Centre Hospitalier de Tourcoing ( Site 4700)
Tourcoing, Nord, France
Hopital Avicenne ( Site 4702)
Bobigny, Seine-Saint-Denis, France
Hopital Hotel Dieu [Paris, France] ( Site 4723)
Paris, , France
A.P.H. Paris, Hopital Saint Louis ( Site 4714)
Paris, , France
Medizinische Hochschule Hannover ( Site 4612)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Bonn ( Site 4600)
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 4607)
Essen, North Rhine-Westphalia, Germany
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)
Berlin, , Germany
EPIMED GmbH ( Site 4608)
Berlin, , Germany
ICH Study Center GmbH & Co.KG ( Site 4609)
Hamburg, , Germany
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)
Modena, Emilia-Romagna, Italy
Ospedale San Gerardo ASST Monza ( Site 5012)
Monza, Monza E Brianza, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)
Milan, , Italy
Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)
Milan, , Italy
Azienda Ospedaliera San Paolo ( Site 5003)
Milan, , Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)
Milan, , Italy
IRCCS Policlinico San Matteo ( Site 5010)
Pavia, , Italy
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)
Roma, , Italy
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)
Roma, , Italy
Center Hospital of the National Center for Global Health and Medicine ( Site 5401)
Tokyo, , Japan
INMENSA ( Site 4506)
Lima, Muni Metro de Lima, Peru
Via Libre ( Site 4500)
Lima, , Peru
Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)
Lima, , Peru
Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)
Guimarães, Braga District, Portugal
Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)
Amadora, Lisbon District, Portugal
Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)
Lisbon, , Portugal
Hospital Geral de Santo Antonio ( Site 4908)
Porto, , Portugal
Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)
Porto, , Portugal
HOPE Clinical Research ( Site 5700)
San Juan, , Puerto Rico
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)
Saint Petersburg, Leningradskaya Oblast', Russia
Infectious Clinical Hospital #2 ( Site 5114)
Moscow, Moscow, Russia
Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)
Samara, Samara Oblast, Russia
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)
Saint Petersburg, Sankt-Peterburg, Russia
Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)
Smolensk, Smolensk Oblast, Russia
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)
Kazan', Tatarstan, Respublika, Russia
FARMOVS ( Site 4805)
Bloemfontein, Free State, South Africa
Wits Clinical HIV Research Unit ( Site 4804)
Johannesburg, Gauteng, South Africa
Ezintsha ( Site 4806)
Johannesburg, Gauteng, South Africa
King Edward Hospital ( Site 4802)
Durban, KwaZulu-Natal, South Africa
Pusan National University Hospital ( Site 5503)
Busan, Pusan-Kwangyokshi, South Korea
Severance Hospital Yonsei University Health System ( Site 5500)
Seoul, , South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol ( Site 5600)
Badalona, Barcelona, Spain
Hospital Clinic i Provincial ( Site 5601)
Barcelona, Catalonia, Spain
Hospital Santa Lucia ( Site 5603)
Cartagena, Murcia, Region de, Spain
Hospital Universitario La Paz ( Site 5604)
Madrid, , Spain
Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Regional Clinical Infectious Hospital ( Site 5614)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)
Kherson, Kherson Oblast, Ukraine
Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)
Kyiv, Kyivska Oblast, Ukraine
Mykolaiv center of paliative assistance and integrated services ( Site 5621)
Mykolayiv, Mykolaiv Oblast, Ukraine
MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)
Odesa, Odesa Oblast, Ukraine
MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)
Berezina, Vinnytsia Oblast, Ukraine
Kyiv City Clinical Hospital 5 ( Site 5616)
Kyiv, , Ukraine
Royal Free Hospital ( Site 5202)
London, Camden, United Kingdom
Western General Hospital ( Site 5201)
Edinburgh, Edinburgh, City of, United Kingdom
Countries
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References
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Carr A, Mngqibisa R, Khaertynova I, Kumar PN, Haider S, Zhang Y, Correll T, Asante-Appiah E, Greaves W. Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1 from a randomized trial. AIDS. 2025 Oct 2. doi: 10.1097/QAD.0000000000004367. Online ahead of print.
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-019
Identifier Type: OTHER
Identifier Source: secondary_id
205243
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-000588-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591A-019
Identifier Type: -
Identifier Source: org_study_id