NCT05766501

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Name: Clinical Trial NCT05766501
Creator: Merck Sharp & Dohme LLC
Keywords: HIV Infection, DOR/ISL, Phase 3, drug, clinical trial, Australia,Canada,Israel,Japan,Puerto Rico,Russian Federation,Taiwan,United States of America

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

Merck Sharp & Dohme LLC·Phase 3·ClinicalTrials.gov·drugRecruiting

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 LLC
Location: Phoenix,Beverly Hills,Los Angeles,Los Angeles,Los Angeles,Sacramento,Washington,Fort Lauderdale,Fort Pierce,Miami Lakes,Miami,Orlando,Orlando,West Palm Beach,Decatur,Macon,Savannah,Kansas City,Hillsbo, Australia,Canada,Israel,Japan,Puerto Rico,Russian Federation,Taiwan,United States of America

Timeline & enrollment

Phase: Phase 3
Start date: Mar 17, 2023
End date: Jan 14, 2026
Enrollment: 1300 participants

Primary outcome

Percentage of Participants with One or More Adverse Event (AE),Percentage of participants who Discontinue Study Intervention Due to an AE

Summary

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

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: NCT05766501
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05766501 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on HIV Infection. Target enrollment is 1300 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.