A Phase 3 interventional study of MK-8591A in HIV-1 Infection, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 93 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
Drug: MK-8591A
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
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC