Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
553
Start Date
2023-02-20
Completion Date
2028-07-11
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (53)
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