DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

NCT05705349 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2023-03-08

Last updated

2025-10-23

Condition(s) studied

HIV-1 Infection

Investigational drug(s) / intervention(s)

DOR/ISLBIC/FTC/TAFPlacebo to DOR/ISLPlacebo to BIC/FTC/TAF

DOR/ISL: Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

BIC/FTC/TAF: Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

Placebo to DOR/ISL: Placebo tablet matched to DOR/ISL tablet taken by mouth.

Placebo to BIC/FTC/TAF: Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Study summary

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening * Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection * If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration Exclusion Criteria: * Has HIV-2 infection * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening * Has active hepatitis B infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\]-positive). * Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \[RNA\]) and lab values are consistent with cirrhosis * Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma * Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Primary outcome measure(s)

Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48 — Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48 — Up to 48 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.
Percentage of participants discontinuing from study treatment due to an AE through Week 48 — Up to 48 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.

Trial sites (131)

Facility	City	Region
Pueblo Family Physicians ( Site 5674)	Phoenix	Arizona
Pacific Oaks Medical Group ( Site 5681)	Beverly Hills	California
Ruane Clinical Research Group, Inc ( Site 5658)	Los Angeles	California
Vivent Health ( Site 5694)	Denver	Colorado
Washington Health Institute ( Site 5689)	Washington D.C.	District of Columbia
Midway Immunology and Research Center ( Site 5657)	Ft. Pierce	Florida
AHF The Kinder Medical Group ( Site 5672)	Miami	Florida
AHF South Beach ( Site 5663)	Miami Beach	Florida
Orlando Immunology Center ( Site 5654)	Orlando	Florida
CAN Community Health - Sarasota ( Site 5668)	Sarasota	Florida
Triple O Research Institute, P.A ( Site 5666)	West Palm Beach	Florida
Emory University and Grady Health System-Medicine ( Site 5690)	Atlanta	Georgia
Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)	Atlanta	Georgia
Atlanta I.D. Group ( Site 5680)	Atlanta	Georgia
Metro Infectious Diseases Consultants L.L.C. ( Site 5653)	Decatur	Georgia
Mercer University, Department of Internal Medicine ( Site 5655)	Macon	Georgia
Rush University Medical Center-Infectious Disease ( Site 5671)	Chicago	Illinois
University of Illinois at Chicago-Project WISH ( Site 5685)	Chicago	Illinois
Howard Brown Health Center-Clinical Research ( Site 5665)	Chicago	Illinois
Be Well Medical Center ( Site 5650)	Berkley	Michigan
Henry Ford Hospital ( Site 5667)	Detroit	Michigan
KC CARE Health Center-Clinical Trials ( Site 5670)	Kansas City	Missouri
Jubilee Clinical Research ( Site 5679)	Las Vegas	Nevada
Las Vegas Research Center ( Site 5691)	Las Vegas	Nevada
ID Care ( Site 5676)	Hillsborough	New Jersey
Saint Michael's Medical Center ( Site 5682)	Newark	New Jersey
Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)	New York	New York
Jacobi Medical Center ( Site 5683)	The Bronx	New York
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)	Charlotte	North Carolina
Regional Center for Infectious Diseases ( Site 5687)	Greensboro	North Carolina
University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)	Cincinnati	Ohio
Central Texas Clinical Research ( Site 5661)	Austin	Texas
St Hope Foundation ( Site 5659)	Bellaire	Texas
Prism Health North Texas, Oak Cliff Health Center ( Site 5660)	Dallas	Texas
North Texas Infectious Diseases Consultants, P.A ( Site 5651)	Dallas	Texas
AXCES Research - Texas - El Paso ( Site 5692)	El Paso	Texas
Texas Centers for Infectious Disease Associates ( Site 5656)	Fort Worth	Texas
DCOL Center for Clinical Research ( Site 5664)	Longview	Texas
Fundación Huésped ( Site 5850)	CABA	Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)	Mar del Plata	Buenos Aires

+ 91 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) Active, not recruiting

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) Active, not recruiting

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) Active, not recruiting

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 NCT05705349 on ClinicalTrials.gov ↗ ← All trials in the UK