A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) [DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
As of Amendment 12, participants will have the option to continue receiving DOR/ISL (100 mg/0.75 mg) until treatment alternatives are identified, or up to Week 288 given that participants are still deriving benefit, based on individual benefit/risk assessment.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20007, United States
Savannah, Georgia 31401, United States
New York, New York 10029, United States
Philadelphia, Pennsylvania 19104, United States
Dallas, Texas 75246, United States
Fort Worth, Texas 76104, United States
Murdock, Western Australia 6150, Australia
Calgary, Alberta T2R 0X7, Canada
Hamilton, Ontario L8S 1A4, Canada
Temuco, Araucania 4781151, Chile
Santiago, Region M. de Santiago 8330034, Chile
Santiago, Region M. de Santiago 8380420, Chile
Nice, Alpes-Maritimes 06202, France
Dijon, Bourgogne-Franche-Comté 21000, France
Bordeaux, Gironde 33075, France
Toulouse, Haute-Garonne 31400, France
Nantes, Loire-Atlantique 44093 Cedex 1, France
Tourcoing, Nord 59200, France
Lyon, Rhone 69004, France
Paris, Île-de-France Region 75010, France
Paris, Île-de-France Region 75013, France
Hanover, Lower Saxony 30625, Germany
Rome, Lazio 00168, Italy
Pavia, Lombardy 27100, Italy
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjyuku-ku, Tokyo 162-8655, Japan
Osaka, 540-0006, Japan
Wroclaw, Lower Silesian Voivodeship 50-136, Poland
Wroclaw, Lower Silesian Voivodeship 50-220, Poland
Ód, Łódź Voivodeship 90-001, Poland
Kemerovo, Kemerovo Oblast 650056, Russia
Krasnoyarsk, Krasnoyarsk Krai 660049, Russia
Saint Petersburg, Leningradskaya Oblast' 196645, Russia
Moscow, Moscow 105275, Russia
Saint Petersburg, Sankt-Peterburg 190020, Russia
Smolensk, Smolensk Oblast 214006, Russia
Kazan', Tatarstan, Respublika 420140, Russia
Badalona, Barcelona 08916, Spain
Madrid, Madrid, Comunidad de 28007, Spain
Madrid, 28040, Spain
Basel, Canton of Aargau 4031, Switzerland
Geneva, Canton of Geneva 1211, Switzerland
Lugano, Canton Ticino 6903, Switzerland
East Sussex, Brighton And Hove BN2 5BE, United Kingdom