Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)) - Trial NCT04223778
Access comprehensive clinical trial information for NCT04223778 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme Corp. and is currently Not yet recruiting. The study focuses on HIV Infection. Target enrollment is 672 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
Feb 18, 2020
Sep 16, 2022
Primary Outcome
Participants with HIV-1 RNA ≥50 copies/mL,Participants with one or more adverse events (AEs) up to Week 48,Participants who discontinued study intervention up to Week 48
Summary
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
 combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
 participants virologically suppressed on a protocol-specified antiretroviral regimen. The
 primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment
 with baseline antiretroviral therapy (ART) as assessed by the proportion of participants with
 HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04223778
Non-Device Trial