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Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT05766501

Public ClinicalTrials.gov record NCT05766501. 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 2, 2026, 1:48 PM 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 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

Brief summary

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

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.

Study identification

NCT ID
NCT05766501
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
641 participants

Conditions and interventions

Conditions

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
Mar 16, 2023
Primary completion
Oct 15, 2025
Completion
Sep 5, 2028
Last update posted
Dec 16, 2025

2023 – 2028

United States locations

U.S. sites
31
U.S. states
12
U.S. cities
28
Facility City State ZIP Site status
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) Birmingham Alabama 35222
Pueblo Family Physicians ( Site 3102) Phoenix Arizona 85015
Pacific Oaks Medical Group ( Site 3123) Beverly Hills California 90211
Kaiser Permanente ( Site 3124) Los Angeles California 90027
Ruane Clinical Research Group, Inc ( Site 3126) Los Angeles California 90036
Mills Clinical Research ( Site 3114) Los Angeles California 90069
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) Sacramento California 95817
Georgetown University Medical Center ( Site 3130) Washington D.C. District of Columbia 20007
Therafirst Medical Center ( Site 3110) Fort Lauderdale Florida 33308
Midway Immunology and Research Center ( Site 3117) Ft. Pierce Florida 34982
AHF The Kinder Medical Group ( Site 3108) Miami Florida 33133
Floridian Clinical Research, LLC ( Site 3133) Miami Lakes Florida 33016
Orlando Immunology Center ( Site 3106) Orlando Florida 32803
Bliss Healthcare Services ( Site 3115) Orlando Florida 32806
CAN Community Health - Sarasota ( Site 3118) Sarasota Florida 34237
Triple O Research Institute, P.A ( Site 3116) West Palm Beach Florida 33407
Augusta University-Infectious Diseases ( Site 3135) Augusta Georgia 30912
Infectious Disease Specialists of Atlanta ( Site 3128) Decatur Georgia 30033
Mercer university, Department of internal medicine-Clinical Research ( Site 3129) Macon Georgia 31201
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) Savannah Georgia 31401
KC CARE Health Center ( Site 3103) Kansas City Missouri 64111
ID Care ( Site 3131) Hillsborough New Jersey 08844
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134) 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 3121) Bellaire Texas 77401
North Texas Infectious Diseases Consultants, P.A ( Site 3100) Dallas Texas 75246
Texas Centers for Infectious Disease Associates ( Site 3111) Fort Worth Texas 76104
The Crofoot Research Center ( Site 3101) Houston Texas 77098
DCOL Center for Clinical Research ( Site 3119) Longview Texas 75605
Private Practice - Dr. Peter Shalit ( Site 3120) Seattle Washington 98104
Multicare Institute for Research and Innovation ( Site 3127) Spokane Washington 99202

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 64 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05766501, 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 16, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05766501 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →