A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Inclusion Criteria:
Exclusion Criteria:
Atlanta, Georgia 30308, United States
Chicago, Illinois 60612, United States
New York, New York 10032, United States
Charlotte, North Carolina 28204, United States
Cincinnati, Ohio 45267-0405, United States
CABA, Buenos Aires C1427CEA, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
Temuco, Araucania 4781151, Chile
Santiago, Region M. de Santiago 8330034, Chile
Santiago, Region M. de Santiago 8380420, Chile
Bogotá, Bogota D.C. 111321, Colombia
Santo Domingo de Guzman, Santo Domingo Province 10305, Dominican Republic
Nice, Alpes-Maritimes 06202, France
München, Bavaria 80336, Germany
Freiburg, Brandenburg 79106, Germany
Guatemala City, 01009, Guatemala
Haifa, 3109601, Israel
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjyuku-ku, Tokyo 162-8655, Japan
Nairobi, Nairobi City 00202, Kenya
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Mexico City, Mexico City 14080, Mexico
Johannesburg, Gauteng 2013, South Africa
Johannesburg, Gauteng 2092, South Africa
Pietermaritzburg, KwaZulu-Natal 3201, South Africa
Cape Town, Western Cape 7500, South Africa
Badalona, Barcelona 08916, Spain
L'Hospitalet de Llobregat,Barcelona, Catalonia 08907, Spain
Madrid, Madrid, Comunidad de 28007, Spain
Madrid, Madrid, Comunidad de 28034, Spain
Barcelona, 08035, Spain
Madrid, 28015, Spain
Geneva, Canton of Geneva 1205, Switzerland
Bangkok, Bangkok 10330, Thailand
Bangkok, Bangkok 10700, Thailand
Chiang Mai, 50200, Thailand
Altindağ, Ankara 06230, Turkey (Türkiye)
Ankara, 06800, Turkey (Türkiye)