- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233216
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
November 15, 2023 updated by: Merck Sharp & Dohme LLC
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection.
It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo.
Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2000
- Holdsworth House Medical Practice ( Site 5300)
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Sydney, New South Wales, Australia, 2010
- St Vincent's Hospital ( Site 5309)
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Queensland
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Brisbane, Queensland, Australia, 4006
- Holdsworth House Medical Practice - Brisbane ( Site 5312)
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health-Monash Medical Centre ( Site 5313)
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital ( Site 5304)
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2C7
- Vancouver ID Research and Care Centre Society ( Site 4100)
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences ( Site 4115)
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute ( Site 4111)
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Toronto, Ontario, Canada, M5G 2N2
- Toronto General Hospital - University Health Network ( Site 4105)
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)
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Araucania
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Temuco, Araucania, Chile, 4781151
- Hospital Dr. Hernan Henriquez Aravena ( Site 4405)
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Region M. De Santiago
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Santiago, Region M. De Santiago, Chile, 8360159
- Fundacion Arriaran ( Site 4401)
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Santiago, Region M. De Santiago, Chile, 8910259
- Centro Cardiovascular Cardiosur ( Site 4407)
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Distrito Capital De Bogota
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Bogota, Distrito Capital De Bogota, Colombia, 111321
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760032
- Fundacion Valle del Lili ( Site 4301)
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Paris, France, 75004
- Hopital Hotel Dieu [Paris, France] ( Site 4723)
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Paris, France, 75010
- A.P.H. Paris, Hopital Saint Louis ( Site 4714)
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Ain
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Lyon, Ain, France, 69003
- Hopital Edouard Herriot ( Site 4726)
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Paris, Ain, France, 75018
- A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06202
- CHU de Nice Hopital Archet 1 ( Site 4703)
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, France, 13003
- Hopital Europeen Marseille ( Site 4717)
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Gironde
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Bordeaux, Gironde, France, 33075
- CHU de Bordeaux- Hopital Saint Andre ( Site 4715)
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Haute-Normandie
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Rouen, Haute-Normandie, France, 76031
- CHU de Rouen ( Site 4705)
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Herault
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Montpellier, Herault, France, 34295
- CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)
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Nord
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Tourcoing, Nord, France, 59208
- Centre Hospitalier de Tourcoing ( Site 4700)
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, France, 93000
- Hopital Avicenne ( Site 4702)
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Berlin, Germany, 10439
- ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)
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Berlin, Germany, 10787
- EPIMED GmbH ( Site 4608)
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Hamburg, Germany, 20146
- ICH Study Center GmbH & Co.KG ( Site 4609)
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30625
- Medizinische Hochschule Hannover ( Site 4612)
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Germany, 53127
- Universitaetsklinikum Bonn ( Site 4600)
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Essen, Nordrhein-Westfalen, Germany, 45122
- Universitaetsklinikum Essen ( Site 4607)
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Milano, Italy, 20122
- Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)
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Milano, Italy, 20127
- Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)
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Milano, Italy, 20142
- Azienda Ospedaliera San Paolo ( Site 5003)
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Milano, Italy, 20157
- ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)
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Pavia, Italy, 27100
- IRCCS Policlinico San Matteo ( Site 5010)
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Roma, Italy, 00149
- Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)
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Roma, Italy, 00168
- Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41124
- Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)
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Monza E Brianza
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Monza, Monza E Brianza, Italy, 20900
- Ospedale San Gerardo ASST Monza ( Site 5012)
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Tokyo, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 5401)
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Seoul, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System ( Site 5500)
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, Korea, Republic of, 49241
- Pusan National University Hospital ( Site 5503)
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Lima, Peru, 15001
- Via Libre ( Site 4500)
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Lima, Peru, 15081
- Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)
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Muni Metro De Lima
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Lima, Muni Metro De Lima, Peru, 15046
- INMENSA ( Site 4506)
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Lisboa, Portugal, 1649-035
- Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)
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Porto, Portugal, 4099-001
- Hospital Geral de Santo Antonio ( Site 4908)
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)
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Braga
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Guimaraes, Braga, Portugal, 4835-044
- Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)
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Lisboa
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Amadora, Lisboa, Portugal, 2720-276
- Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)
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San Juan, Puerto Rico, 00909
- HOPE Clinical Research ( Site 5700)
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Leningradskaya Oblast
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Saint Petersburg, Leningradskaya Oblast, Russian Federation
- Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)
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Moskva
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Moscow, Moskva, Russian Federation, 105275
- Infectious Clinical Hospital #2 ( Site 5114)
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Samarskaya Oblast
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Samara, Samarskaya Oblast, Russian Federation, 443124
- Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 196645
- FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)
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Smolenskaya Oblast
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Smolensk, Smolenskaya Oblast, Russian Federation, 214006
- Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)
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Sverdlovskaya Oblast
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Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620102
- Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)
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Tatarstan, Respublika
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Kazan, Tatarstan, Respublika, Russian Federation, 420140
- Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)
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Free State
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Bloemfontein, Free State, South Africa, 9301
- FARMOVS ( Site 4805)
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Gauteng
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Johannesburg, Gauteng, South Africa, 2041
- Wits Clinical HIV Research Unit ( Site 4804)
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Johannesburg, Gauteng, South Africa, 2193
- Ezintsha ( Site 4806)
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Kwazulu-Natal
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Durban, Kwazulu-Natal, South Africa, 4013
- King Edward Hospital ( Site 4802)
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Madrid, Spain, 28046
- Hospital Universitario La Paz ( Site 5604)
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol ( Site 5600)
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Cataluna
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Barcelona, Cataluna, Spain, 08036
- Hospital Clinic i Provincial ( Site 5601)
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Murcia, Region De
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Cartagena, Murcia, Region De, Spain, 30202
- Hospital Santa Lucia ( Site 5603)
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Kyiv, Ukraine, 03115
- Kyiv City Clinical Hospital 5 ( Site 5616)
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Dnipropetrovska Oblast
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Dnipro, Dnipropetrovska Oblast, Ukraine, 49115
- Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)
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Kharkivska Oblast
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Kharkiv, Kharkivska Oblast, Ukraine, 61096
- Regional Clinical Infectious Hospital ( Site 5614)
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Khersonska Oblast
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Kherson, Khersonska Oblast, Ukraine, 73000
- Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)
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Kyivska Oblast
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Kyiv, Kyivska Oblast, Ukraine, 03038
- Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)
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Mykolaivska Oblast
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Mykolaiv, Mykolaivska Oblast, Ukraine, 54003
- Mykolaiv center of paliative assistance and integrated services ( Site 5621)
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Odeska Oblast
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Odesa, Odeska Oblast, Ukraine, 65014
- MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)
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Vinnytska Oblast
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Berezina, Vinnytska Oblast, Ukraine, 23222
- MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)
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Camden
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London, Camden, United Kingdom, NW3 2QG
- Royal Free Hospital ( Site 5202)
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Edinburgh, City Of
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Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU
- Western General Hospital ( Site 5201)
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Alabama
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Birmingham, Alabama, United States, 35222
- University of Alabama at Birmingham 1917 Research Clinic ( Site 4031)
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California
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Los Angeles, California, United States, 90069
- Men's Health Foundation ( Site 4018)
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Palm Springs, California, United States, 92262
- Palmtree Clinical Research, Inc. ( Site 4016)
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale School of Medicine ( Site 4007)
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Hospital ( Site 4015)
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Florida
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Miami, Florida, United States, 33133
- The Kinder Medical Group ( Site 4014)
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Orlando, Florida, United States, 32803
- Orlando Immunology Center ( Site 4012)
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West Palm Beach, Florida, United States, 33407
- Triple O Research Institute, P.A. ( Site 4020)
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Georgia
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Savannah, Georgia, United States, 31410
- Chatham County Health Department ( Site 4029)
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Illinois
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Chicago, Illinois, United States, 60613
- Howard Brown Health Center ( Site 4006)
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Chicago, Illinois, United States, 60657
- Northstar Healthcare ( Site 4004)
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland ( Site 4023)
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Mississippi
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Jackson, Mississippi, United States, 39216
- The University of Mississippi Medical Center ( Site 4036)
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New Jersey
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Newark, New Jersey, United States, 07102
- Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai ( Site 4000)
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill ( Site 4026)
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Texas
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Bellaire, Texas, United States, 77401
- Saint Hope Foundation, Inc. ( Site 4034)
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Dallas, Texas, United States, 75246
- North Texas Infectious Diseases Consultants, PA ( Site 4005)
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Washington
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Seattle, Washington, United States, 98104
- Dr. Peter Shalit, MD ( Site 4002)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Is HIV-1 positive.
- 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 HIV type 2 (HIV-2) infection.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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ISL 0.75 mg capsule taken by mouth.
Other Names:
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
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Experimental: 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.
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DOR 100 mg tablet taken by mouth.
Other Names:
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
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Experimental: 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.
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100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
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Placebo Comparator: 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.
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Placebo capsule matched to ISL taken by mouth.
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
Placebo tablet matched to DOR taken by mouth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
Time Frame: Day 1 (baseline) and Day 8
|
Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure.
|
Day 1 (baseline) and Day 8
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Percentage of Participants With ≥1 AEs Through Week 49
Time Frame: Up to 49 weeks
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Up to 49 weeks
|
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
Time Frame: Up to 25 weeks
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Up to 25 weeks
|
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25
Time Frame: Up to 25 weeks
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Up to 25 weeks
|
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49
Time Frame: Up to 49 weeks
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Up to 49 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97
Time Frame: Up to 97 weeks
|
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.
|
Up to 97 weeks
|
Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97
Time Frame: Up to 97 weeks
|
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.
|
Up to 97 weeks
|
Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
Time Frame: Day 1 (baseline) and Day 8
|
Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure.
Participants treated with DOR/ISL FDC were not analyzed in this outcome measure.
|
Day 1 (baseline) and Day 8
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Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment
Time Frame: Day 1 (baseline) and Day 8
|
The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
Time Frame: Day 1 (baseline) and Day 8
|
Participants with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL
|
Day 1 (baseline) and Day 8
|
Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Time Frame: Day 1 (baseline) and Day 8
|
Participants with a ≥0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure.
Participants treated with placebo were not analyzed in this outcome measure.
|
Day 1 (baseline) and Day 8
|
Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment
Time Frame: Day 1 (baseline) and Day 8
|
The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the t-distribution.
The group treated with placebo were not analyzed in this outcome measure.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Time Frame: Day 1 (baseline) and Day 8
|
Participants receiving DOR/ISL with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure.
Participants treated with placebo were not analyzed in this outcome measure.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 25
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 25
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 49
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 49
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 97
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 97
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 25
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 25
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 49
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 49
|
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 97
|
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 97
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 25
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 25
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 49
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 49
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
Time Frame: Day 1 (baseline) and Week 97
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 97
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 25
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 25
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 49
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 49
|
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
Time Frame: Day 8 (baseline) and Week 97
|
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 97
|
Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 25
|
The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 25
|
Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 49
|
The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 49
|
Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 97
|
The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 97
|
Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 25
|
The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 25
|
Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 49
|
The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 49
|
Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 97
|
The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 97
|
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL
Time Frame: Day 1 (baseline) and Day 8
|
The percentage of participants with HIV-1 RNA <200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL
Time Frame: Day 1 (baseline) and Day 8
|
The percentage of participants with HIV-1 RNA <50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL
Time Frame: Day 1 (baseline) and Day 8
|
The percentage of participants with HIV-1 RNA <40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
|
Day 1 (baseline) and Day 8
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25
Time Frame: Week 25
|
The percentage of participants with HIV-1 RNA <200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49
Time Frame: Week 49
|
The percentage of participants with HIV-1 RNA <200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 49
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97
Time Frame: Week 97
|
The percentage of participants with HIV-1 RNA <200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 97
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25
Time Frame: Week 25
|
The percentage of participants with HIV-1 RNA <50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49
Time Frame: Week 49
|
The percentage of participants with HIV-1 RNA <50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 49
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97
Time Frame: Week 97
|
The percentage of participants with HIV-1 RNA <50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 97
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25
Time Frame: Week 25
|
The percentage of participants with HIV-1 RNA <40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49
Time Frame: Week 49
|
The percentage of participants with HIV-1 RNA <40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol.
|
Week 49
|
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97
Time Frame: Week 97
|
The percentage of participants with HIV-1 RNA <40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Analysis of the pooled treatment group was planned per protocol,
|
Week 97
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25
Time Frame: Week 25
|
The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100.
RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49
Time Frame: Week 49
|
The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100.
RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 49
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25
Time Frame: Week 25
|
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100.
The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49
Time Frame: Week 49
|
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100.
The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 49
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25
Time Frame: Week 25
|
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100.
The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 25
|
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49
Time Frame: Week 49
|
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100.
The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
|
Week 49
|
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25
Time Frame: Week 25
|
The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
|
Week 25
|
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49
Time Frame: Week 49
|
The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
|
Week 49
|
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97
Time Frame: Week 97
|
The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
|
Week 97
|
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25
Time Frame: Week 25
|
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25 is presented.
.Analysis of the pooled treatment group was planned per protocol,
|
Week 25
|
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49
Time Frame: Week 49
|
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49 is presented.
.Analysis of the pooled treatment group was planned per protocol,
|
Week 49
|
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97
Time Frame: Week 97
|
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97 is presented.
.Analysis of the pooled treatment group was planned per protocol,
|
Week 97
|
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 25
|
The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 25
|
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 49
|
The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 49
|
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Time Frame: Day 1 (baseline) and Week 97
|
The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 1 (baseline) and Week 97
|
Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 25
|
The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 25
|
Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 49
|
The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 49
|
Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Time Frame: Day 8 (baseline) and Week 97
|
The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory..
The within-group 95% CIs were calculated based on the t-distribution.
Analysis of the pooled treatment group was planned per protocol,
|
Day 8 (baseline) and Week 97
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2020
Primary Completion (Actual)
November 21, 2022
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 15, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8591A-019
- MK-8591A-019 (Other Identifier: Merck)
- 205243 (Registry Identifier: JAPIC-CTI)
- 2019-000588-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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