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NCT05631093Active, not recruitingPhase 3

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)

A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
553 (actual)
First submitted
18 Nov 2022
Start date
20 Feb 2023
Primary completion date
10 Oct 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT05631093
EU CT number
2022-502127-22-00
EudraCT number
2022-502127-22

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 553
  • From 20 Feb 2023 to the primary completion date, 10 Oct 2024
  • 53 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
  • 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

Other illness

  • Has HIV-2 infection
  • Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has active hepatitis B virus (HBV) infection
  • Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
  • Has taken long-acting HIV therapy at any time

Age

  • Has a ≤5 years prior history of malignancy

Other

  • Has a documented or known virologic resistance to Doravine (DOR)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Holdsworth House Medical Practice - Brisbane ( Site 4201)
Coordinator of this site? Confirm its status
BrisbaneAustraliaUnknown status
Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204)
Coordinator of this site? Confirm its status
BrisbaneAustraliaUnknown status
Holdsworth House Medical Practice ( Site 4200)
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Prahran Market Clinic ( Site 4202)
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
St Vincent's Hospital-IBAC ( Site 4203)
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104)
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Clinique Medicale lActuel-Clinical Research ( Site 3100)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Clinique de médecine Urbaine du Quartier Latin ( Site 3101)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Toronto General Hospital ( Site 3102)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Maple Leaf Research ( Site 3103)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
University Hospital Basel-Infectiology ( Site 4002)
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Inselspital Bern-Inselspital Infektiologie ( Site 4003)
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4004)
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
CHUV (centre hospitalier universitaire vaudois) ( Site 4006)
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4005)
Coordinator of this site? Confirm its status
LuganoSwitzerlandUnknown status
UniversitätsSpital Zürich ( Site 4000)
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Ciensalud Ips S A S ( Site 3300)
Coordinator of this site? Confirm its status
BarranquillaColombiaUnknown status
Clinica de la Costa S.A.S. ( Site 3305)
Coordinator of this site? Confirm its status
BarranquillaColombiaUnknown status
Fundacion Valle del Lili- CIC ( Site 3302)
Coordinator of this site? Confirm its status
CaliColombiaUnknown status
Heartlands Hospital ( Site 4102)
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status
North Manchester General Hospital ( Site 4107)
Coordinator of this site? Confirm its status
CrumpsallUnited KingdomUnknown status
Brighton and Sussex University Hospitals NHS Trust ( Site 4104)
Coordinator of this site? Confirm its status
East SussexUnited KingdomUnknown status
Royal Free Hospital ( Site 4101)
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
King's College Hospital ( Site 4108)
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Royal London Hospital ( Site 4100)
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Royal Victoria Infirmary ( Site 4105)
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status
National Hospital Organization Nagoya Medical Center ( Site 4403)
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Tokyo Medical University Hospital ( Site 4404)
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Center Hospital of the National Center for Global Health and Medicine ( Site 4401)
Coordinator of this site? Confirm its status
Shinjyuku-kuJapanUnknown status
Central Texas Clinical Research ( Site 3015)
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Infectious Disease Specialists of Atlanta ( Site 3003)
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
Midway Immunology and Research Center ( Site 3009)
Coordinator of this site? Confirm its status
Ft. PierceUnited StatesUnknown status
ID Care ( Site 3041)
Coordinator of this site? Confirm its status
HillsboroughUnited StatesUnknown status
The Crofoot Research Center ( Site 3040)
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
DCOL Center for Clinical Research ( Site 3022)
Coordinator of this site? Confirm its status
LongviewUnited StatesUnknown status
Kaiser Permanente-Infectious Disease ( Site 3014)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Orlando Immunology Center ( Site 3004)
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Palmtree Clinical Research ( Site 3032)
Coordinator of this site? Confirm its status
Palm SpringsUnited StatesUnknown status
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
CAN Community Health - Sarasota ( Site 3017)
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028)
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Georgetown University Medical Center ( Site 3006)
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status
Triple O Research Institute, P.A ( Site 3026)
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status
Josha Research ( Site 3903)
Coordinator of this site? Confirm its status
BloemfonteinSouth AfricaUnknown status
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status
Desmond Tutu Health Foundation ( Site 3902)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status
Wentworth Hospital ( Site 3904)
Coordinator of this site? Confirm its status
DurbanSouth AfricaUnknown status
Helen Joseph Hospital ( Site 3910)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
Ezintsha-Clinical Research Site ( Site 3907)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
Be Part Yoluntu Centre ( Site 3901)
Coordinator of this site? Confirm its status
PaarlSouth AfricaUnknown status
Private Practice Dr. Marleen de Jager ( Site 3900)
Coordinator of this site? Confirm its status
PretoriaSouth AfricaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.