HomeTrialNCT05631093
🔬NCT05631093Phase 3ACTIVE NOT RECRUITING

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

Study Summary

The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

Conditions
Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment553 participants
Primary Completion
Lead SponsorMerck Sharp & Dohme LLC
Data Retrieved2026-04-11 02:55:36.206630+00:00
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