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)
NCT ID: NCT05631093
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
553 participants
INTERVENTIONAL
2023-02-20
2028-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) receive doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).
DOR/ISL
Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.
ART + DOR/ISL
Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first).
ART
Standard of care ART, per approved product list, taken orally
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Kaiser Permanente-Infectious Disease ( Site 3014)
Los Angeles, California, United States
Palmtree Clinical Research ( Site 3032)
Palm Springs, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30
San Francisco, California, United States
Georgetown University Medical Center ( Site 3006)
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 3009)
Ft. Pierce, Florida, United States
Orlando Immunology Center ( Site 3004)
Orlando, Florida, United States
CAN Community Health - Sarasota ( Site 3017)
Sarasota, Florida, United States
Triple O Research Institute, P.A ( Site 3026)
West Palm Beach, Florida, United States
Infectious Disease Specialists of Atlanta ( Site 3003)
Decatur, Georgia, United States
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028)
Savannah, Georgia, United States
ID Care ( Site 3041)
Hillsborough, New Jersey, United States
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
Philadelphia, Pennsylvania, United States
Central Texas Clinical Research ( Site 3015)
Austin, Texas, United States
The Crofoot Research Center ( Site 3040)
Houston, Texas, United States
DCOL Center for Clinical Research ( Site 3022)
Longview, Texas, United States
Holdsworth House Medical Practice ( Site 4200)
Darlinghurst, New South Wales, Australia
St Vincent's Hospital-IBAC ( Site 4203)
Sydney, New South Wales, Australia
Holdsworth House Medical Practice - Brisbane ( Site 4201)
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204)
Brisbane, Queensland, Australia
Prahran Market Clinic ( Site 4202)
Melbourne, Victoria, Australia
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104)
Hamilton, Ontario, Canada
Maple Leaf Research ( Site 3103)
Toronto, Ontario, Canada
Toronto General Hospital ( Site 3102)
Toronto, Ontario, Canada
Clinique de médecine Urbaine du Quartier Latin ( Site 3101)
Montreal, Quebec, Canada
Clinique Medicale lActuel-Clinical Research ( Site 3100)
Montreal, Quebec, Canada
Ciensalud Ips S A S ( Site 3300)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 3305)
Barranquilla, Atlántico, Colombia
Fundacion Valle del Lili- CIC ( Site 3302)
Cali, Valle del Cauca Department, Colombia
National Hospital Organization Nagoya Medical Center ( Site 4403)
Nagoya, Aichi-ken, Japan
Tokyo Medical University Hospital ( Site 4404)
Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 4401)
Shinjyuku-ku, Tokyo, Japan
Josha Research ( Site 3903)
Bloemfontein, Free State, South Africa
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 3905)
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital ( Site 3910)
Johannesburg, Gauteng, South Africa
Ezintsha-Clinical Research Site ( Site 3907)
Johannesburg, Gauteng, South Africa
Private Practice Dr. Marleen de Jager ( Site 3900)
Pretoria, Gauteng, South Africa
Wentworth Hospital ( Site 3904)
Durban, KwaZulu-Natal, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 3908)
Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation ( Site 3902)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 3901)
Paarl, Western Cape, South Africa
University Hospital Basel-Infectiology ( Site 4002)
Basel, Canton of Basel-City, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4004)
Geneva, Canton of Geneva, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 4006)
Lausanne, Canton of Vaud, Switzerland
UniversitätsSpital Zürich ( Site 4000)
Zurich, Canton of Zurich, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4005)
Lugano, Canton Ticino, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 4003)
Bern, , Switzerland
Brighton and Sussex University Hospitals NHS Trust ( Site 4104)
East Sussex, Brighton And Hove, United Kingdom
North Manchester General Hospital ( Site 4107)
Crumpsall, England, United Kingdom
Royal London Hospital ( Site 4100)
London, England, United Kingdom
Royal Free Hospital ( Site 4101)
London, England, United Kingdom
Royal Victoria Infirmary ( Site 4105)
Newcastle upon Tyne, England, United Kingdom
King's College Hospital ( Site 4108)
London, London, City of, United Kingdom
Heartlands Hospital ( Site 4102)
Birmingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-8591A-051
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031220698
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1283-3894
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-502127-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-502127-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591A-051
Identifier Type: -
Identifier Source: org_study_id
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