Pure Global
NCT04223778

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017))

A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
Merck Sharp & Dohme Corp.·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
HIV Infection
Drug/Device/Intervention
DOR/ISL
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Merck Sharp & Dohme Corp.
Location
Washington,Fort Pierce,Orlando,Orlando,West Palm Beach,Savannah,Chicago,Kansas City,Hillsborough,Chapel Hill,Philadelphia,Bellaire,Dallas,Fort Worth,Houston,Sydney,Herston,Carlton,Murdoch,Calgary,Vanc, Australia,Canada,Chile,Colombia,France,Italy,Japan,New Zealand,Poland,Russian Federation,South Afric
Timeline & enrollment
Phase
Phase 3
Start date
Feb 18, 2020
End date
Sep 16, 2022
Enrollment
672 participants
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
HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04223778
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.