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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks
Participants with serious adverse events (SAEs)
Percentage of participants with serious adverse events (SAEs)
Time frame: Up to Week 198
Participants who discontinued due to an adverse event (AE)
Percentage of participants who discontinued study treatment due to an AE.
Time frame: Up to Week 192
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Pueblo Family Physicians ( Site 0010)
Phoenix, Arizona, United States
One Community Health ( Site 0045)
Sacramento, California, United States
Whitman-Walker Institute ( Site 0039)
Washington D.C., District of Columbia, United States
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 0033)
Ft. Pierce, Florida, United States
Orlando Immunology Center ( Site 0017)
Orlando, Florida, United States
Bliss Healthcare Services-Research ( Site 0030)
Orlando, Florida, United States
Triple O Research Institute, P.A ( Site 0031)
West Palm Beach, Florida, United States
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
Savannah, Georgia, United States
Northstar Healthcare ( Site 0003)
Chicago, Illinois, United States
...and 83 more locations