NCT04223791

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)

Name: Clinical Trial NCT04223791
Creator: Merck Sharp & Dohme Corp.
Keywords: HIV Infection, DOR/ISL, Phase 3, drug, clinical trial, Australia,Austria,Canada,Finland,France,Germany,Italy,Japan,Puerto Rico,Spain,United States of Ameri

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV- 1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

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: Phoenix,Beverly Hills,Los Angeles,Los Angeles,Palm Springs,Sacramento,San Francisco,Washington,Fort Lauderdale,Fort Pierce,Miami Beach,Miami,Orlando,West Palm Beach,Augusta,Decatur,Macon,Savannah,Minn, Australia,Austria,Canada,Finland,France,Germany,Italy,Japan,Puerto Rico,Spain,United States of Ameri

Timeline & enrollment

Phase: Phase 3
Start date: Feb 18, 2020
End date: Aug 31, 2023
Enrollment: 643 participants

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

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: NCT04223791
Type: Non-Device Trial

About this record

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.

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.