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Study identifier: NCT04233879 Synced from ClinicalTrials.gov · August 04, 2026
● Completed

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Condition: HIV-1 Infection  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 3
Planned participants599
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (95)

University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)Birmingham, Alabama, United States
Pueblo Family Physicians ( Site 5606)Phoenix, Arizona, United States
Ruane Clinical Research Group, Inc. ( Site 5624)Los Angeles, California, United States
Midway Immunology and Research ( Site 5622)Ft. Pierce, Florida, United States
The Kinder Medical Group ( Site 5615)Miami, Florida, United States
Floridian Clinical Research, LLC ( Site 5625)Miami Lakes, Florida, United States
Orlando Immunology Center ( Site 5613)Orlando, Florida, United States
CAN Community Health ( Site 5627)Sarasota, Florida, United States
Triple O Research Institute, P.A. ( Site 5621)West Palm Beach, Florida, United States
Columbus Regional Research Institute ( Site 5616)Columbus, Georgia, United States
Infectious Disease Specialists Of Atlanta PC ( Site 5608)Decatur, Georgia, United States
Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)Minneapolis, Minnesota, United States

+ 83 more locations — full list on the registry record.

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