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)

NCT05631093 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2023-02-20

Last updated

2025-11-21

Condition(s) studied

HIV-1 Infection

Investigational drug(s) / intervention(s)

ARTDOR/ISL

ART: Standard of care ART, per approved product list, taken orally

DOR/ISL: Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.

Study summary

The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \<50 copies/mL at screening * Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen * Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator 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 acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening * Has active hepatitis B virus (HBV) infection * Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis * Has a ≤5 years prior history of malignancy * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers * Has taken long-acting HIV therapy at any time * Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period * Has a documented or known virologic resistance to Doravine (DOR)

Primary outcome measure(s)

Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48 — Week 48
HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Percentage of Participants With One or More Adverse Events (AEs) at Week 48 — Up to Week 48
An AE is defined as 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. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported.
Percentage of Participants With an AE Leading to Discontinuation of Study Intervention at Week 48 — Up to Week 48
An AE is defined as 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. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported.

Trial sites (53)

Facility	City	Region
Kaiser Permanente-Infectious Disease ( Site 3014)	Los Angeles	California
Palmtree Clinical Research ( Site 3032)	Palm Springs	California
Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30	San Francisco	California
Georgetown University Medical Center ( Site 3006)	Washington D.C.	District of Columbia
Midway Immunology and Research Center ( Site 3009)	Ft. Pierce	Florida
Orlando Immunology Center ( Site 3004)	Orlando	Florida
CAN Community Health - Sarasota ( Site 3017)	Sarasota	Florida
Triple O Research Institute, P.A ( Site 3026)	West Palm Beach	Florida
Infectious Disease Specialists of Atlanta ( Site 3003)	Decatur	Georgia
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028)	Savannah	Georgia
ID Care ( Site 3041)	Hillsborough	New Jersey
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site	Philadelphia	Pennsylvania
Central Texas Clinical Research ( Site 3015)	Austin	Texas
The Crofoot Research Center ( Site 3040)	Houston	Texas
DCOL Center for Clinical Research ( Site 3022)	Longview	Texas
Holdsworth House Medical Practice ( Site 4200)	Darlinghurst	New South Wales
St Vincent's Hospital-IBAC ( Site 4203)	Sydney	New South Wales
Holdsworth House Medical Practice - Brisbane ( Site 4201)	Brisbane	Queensland
Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204)	Brisbane	Queensland
Prahran Market Clinic ( Site 4202)	Melbourne	Victoria
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104)	Hamilton	Ontario
Maple Leaf Research ( Site 3103)	Toronto	Ontario
Toronto General Hospital ( Site 3102)	Toronto	Ontario
Clinique de médecine Urbaine du Quartier Latin ( Site 3101)	Montreal	Quebec
Clinique Medicale lActuel-Clinical Research ( Site 3100)	Montreal	Quebec
Ciensalud Ips S A S ( Site 3300)	Barranquilla	Atlántico
Clinica de la Costa S.A.S. ( Site 3305)	Barranquilla	Atlántico
Fundacion Valle del Lili- CIC ( Site 3302)	Cali	Valle del Cauca Department
National Hospital Organization Nagoya Medical Center ( Site 4403)	Nagoya	Aichi-ken
Tokyo Medical University Hospital ( Site 4404)	Shinjuku-ku	Tokyo
Center Hospital of the National Center for Global Health and Medicine ( Site 4401)	Shinjyuku-ku	Tokyo
Josha Research ( Site 3903)	Bloemfontein	Free State
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905)	Johannesburg	Gauteng
Helen Joseph Hospital ( Site 3910)	Johannesburg	Gauteng
Ezintsha-Clinical Research Site ( Site 3907)	Johannesburg	Gauteng
Private Practice Dr. Marleen de Jager ( Site 3900)	Pretoria	Gauteng
Wentworth Hospital ( Site 3904)	Durban	KwaZulu-Natal
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908)	Cape Town	Western Cape
Desmond Tutu Health Foundation ( Site 3902)	Cape Town	Western Cape
Be Part Yoluntu Centre ( Site 3901)	Paarl	Western Cape

+ 13 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

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) 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 NCT05631093 on ClinicalTrials.gov ↗ ← All trials in the UK