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)

NCT05766501 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2023-03-17

Last updated

2025-12-17

Condition(s) studied

HIV Infection

Investigational drug(s) / intervention(s)

DOR/ISL

DOR/ISL: FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]). Exclusion Criteria: * Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033. * Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL. * Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Primary outcome measure(s)

Percentage of Participants with One or More Adverse Event (AE) — Up to 96 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented.
Percentage of participants who Discontinue Study Intervention Due to an AE — Up to 96 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.

Trial sites (95)

Facility	City	Region
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)	Birmingham	Alabama
Pueblo Family Physicians ( Site 3102)	Phoenix	Arizona
Pacific Oaks Medical Group ( Site 3123)	Beverly Hills	California
Kaiser Permanente ( Site 3124)	Los Angeles	California
Ruane Clinical Research Group, Inc ( Site 3126)	Los Angeles	California
Mills Clinical Research ( Site 3114)	Los Angeles	California
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)	Sacramento	California
Georgetown University Medical Center ( Site 3130)	Washington D.C.	District of Columbia
Therafirst Medical Center ( Site 3110)	Fort Lauderdale	Florida
Midway Immunology and Research Center ( Site 3117)	Ft. Pierce	Florida
AHF The Kinder Medical Group ( Site 3108)	Miami	Florida
Floridian Clinical Research, LLC ( Site 3133)	Miami Lakes	Florida
Orlando Immunology Center ( Site 3106)	Orlando	Florida
Bliss Healthcare Services ( Site 3115)	Orlando	Florida
CAN Community Health - Sarasota ( Site 3118)	Sarasota	Florida
Triple O Research Institute, P.A ( Site 3116)	West Palm Beach	Florida
Augusta University-Infectious Diseases ( Site 3135)	Augusta	Georgia
Infectious Disease Specialists of Atlanta ( Site 3128)	Decatur	Georgia
Mercer university, Department of internal medicine-Clinical Research ( Site 3129)	Macon	Georgia
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)	Savannah	Georgia
KC CARE Health Center ( Site 3103)	Kansas City	Missouri
ID Care ( Site 3131)	Hillsborough	New Jersey
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)	New York	New York
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site	Philadelphia	Pennsylvania
St Hope Foundation ( Site 3121)	Bellaire	Texas
North Texas Infectious Diseases Consultants, P.A ( Site 3100)	Dallas	Texas
Texas Centers for Infectious Disease Associates ( Site 3111)	Fort Worth	Texas
The Crofoot Research Center ( Site 3101)	Houston	Texas
DCOL Center for Clinical Research ( Site 3119)	Longview	Texas
Private Practice - Dr. Peter Shalit ( Site 3120)	Seattle	Washington
Multicare Institute for Research and Innovation ( Site 3127)	Spokane	Washington
Instituto Oulton ( Site 1004)	Córdoba	Córdoba Province
Instituto CAICI SRL ( Site 1003)	Rosario	Santa Fe Province
Helios Salud ( Site 1002)	Buenos Aires	Argentina
Fundación Huésped ( Site 1001)	Buenos Aires	Argentina
Fundación IDEAA ( Site 1005)	Buenos Aires	Argentina
Holdsworth House Medical Practice ( Site 1100)	Darlinghurst	New South Wales
St Vincent's Hospital-IBAC ( Site 1103)	Sydney	New South Wales
Holdsworth House Medical Practice - Brisbane ( Site 1101)	Brisbane	Queensland
Prahran Market Clinic ( Site 1102)	Melbourne	Victoria

+ 55 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05766501 on ClinicalTrials.gov ↗ ← All trials in the UK