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Active, not recruiting Phase 3 Interventional

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

ClinicalTrials.gov ID: NCT04776252

Public ClinicalTrials.gov record NCT04776252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

Study identification

NCT ID
NCT04776252
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
2,000 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2021
Primary completion
May 28, 2029
Completion
May 28, 2029
Last update posted
Dec 22, 2025

2021 – 2029

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Pueblo Family Physicians ( Site 0010) Phoenix Arizona 85015
One Community Health ( Site 0045) Sacramento California 95811
Whitman-Walker Institute ( Site 0039) Washington D.C. District of Columbia 20005
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 Washington D.C. District of Columbia 20007
Midway Immunology and Research Center ( Site 0033) Ft. Pierce Florida 34982
Orlando Immunology Center ( Site 0017) Orlando Florida 32803
Bliss Healthcare Services-Research ( Site 0030) Orlando Florida 32806
Triple O Research Institute, P.A ( Site 0031) West Palm Beach Florida 33407
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015) Savannah Georgia 31401
Northstar Healthcare ( Site 0003) Chicago Illinois 60657
KC CARE Health Center-Clinical Trials ( Site 0012) Kansas City Missouri 64111
ID Care ( Site 0028) Hillsborough New Jersey 08844
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006) New York New York 10029
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site Philadelphia Pennsylvania 19104
St Hope Foundation ( Site 0041) Bellaire Texas 77401
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) Dallas Texas 75246
Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) Fort Worth Texas 76104
The Crofoot Research Center ( Site 0008) Houston Texas 77098

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04776252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 22, 2025 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04776252 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →