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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, 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; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind 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 Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2023-02-17
Completion Date
2028-08-04
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
DOR/ISL
DOR/ISL 100 mg/0.25 mg oral tablets once daily
BIC/FTC/TAF
BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily
Placebo to BIC/FTC/TAF
0 mg oral tablets once daily
Placebo to DOR/ISL
0 mg oral tablets once daily
Locations (49)
Pueblo Family Physicians ( Site 1425)
Phoenix, Arizona, United States
Pacific Oaks Medical Group ( Site 1400)
Beverly Hills, California, United States
Ruane Clinical Research Group, Inc ( Site 1414)
Los Angeles, California, United States
Mills Clinical Research ( Site 1433)
Los Angeles, California, United States
Whitman-Walker Institute ( Site 1431)
Washington D.C., District of Columbia, United States
Therafirst Medical Center ( Site 1402)
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center ( Site 1401)
Ft. Pierce, Florida, United States
AHF The Kinder Medical Group ( Site 1426)
Miami, Florida, United States
Orlando Immunology Center ( Site 1407)
Orlando, Florida, United States
Triple O Research Institute, P.A ( Site 1417)
West Palm Beach, Florida, United States
Infectious Disease Specialists of Atlanta ( Site 1403)
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine ( Site 1411)
Macon, Georgia, United States
AccessHealth MA ( Site 1419)
Boston, Massachusetts, United States
Be Well Medical Center ( Site 1408)
Berkley, Michigan, United States
KC CARE Health Center-Clinical Trials ( Site 1422)
Kansas City, Missouri, United States
Las Vegas Research Center ( Site 1436)
Las Vegas, Nevada, United States
Regional Center for Infectious Disease Research ( Site 1435)
Greensboro, North Carolina, United States
Central Texas Clinical Research ( Site 1413)
Austin, Texas, United States
St Hope Foundation ( Site 1410)
Bellaire, Texas, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 1409)
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A ( Site 1404)
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates ( Site 1406)
Fort Worth, Texas, United States
The Crofoot Research Center ( Site 1424)
Houston, Texas, United States
DCOL Center for Clinical Research ( Site 1415)
Longview, Texas, United States
Holdsworth House Medical Practice ( Site 6200)
Darlinghurst, New South Wales, Australia
St Vincent's Hospital-IBAC ( Site 6203)
Sydney, New South Wales, Australia
Holdsworth House Medical Practice - Brisbane ( Site 6201)
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204)
Brisbane, Queensland, Australia
Prahran Market Clinic ( Site 6202)
Melbourne, Victoria, Australia
Clinica Universidad Catolica del Maule ( Site 2204)
Talca, Maule Region, Chile
Clínica Universidad de Los Andes ( Site 2206)
Santiago, Region M. de Santiago, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200)
Santiago, Region M. de Santiago, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205)
Temuco, Región de la Araucanía, Chile
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801)
Haifa, Israel
Hadassah Medical Center-Infecious Disease ( Site 4802)
Jerusalem, Israel
Sheba Medical Center-HIV unit ( Site 4803)
Ramat Gan, Israel
Sourasky Medical Center ( Site 4804)
Tel Aviv, Israel
National Hospital Organization Nagoya Medical Center ( Site 6603)
Nagoya, Aichi-ken, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 6601)
Shinjyuku-ku, Tokyo, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66
Osaka, Japan
Southmead Hospital ( Site 5805)
Bristol, Bristol, City of, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 5809)
Birmingham, England, United Kingdom
Royal Liverpool University Hospital ( Site 5812)
Liverpool, England, United Kingdom
Royal London Hospital ( Site 5800)
London, England, United Kingdom
Royal Free Hospital ( Site 5801)
London, England, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 5808)
London, London, City of, United Kingdom
The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810)
London, London, City of, United Kingdom
University Hospital of Wales ( Site 5803)
Cardiff, Wales, United Kingdom
Royal Berkshire Hospital ( Site 5813)
Reading, United Kingdom