Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) - Trial NCT04223791
Access comprehensive clinical trial information for NCT04223791 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 643 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
Feb 18, 2020
Aug 31, 2023
Primary Outcome
Participants with (Human Immunodeficiency Virus 1 ribonucleic acid ) HIV-1 RNA ≥50 copies/mL at Week 48,Participants with one or more adverse events (AEs) up to Week 48,Participants who discontinued study intervention due to an AE 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 regimen of bictegravir/emtricitabine/tenofovir
 alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be
 non-inferior to continued treatment with BIC/FTC/TAF 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
NCT04223791
Non-Device Trial