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A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
Official title: A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
570
Start Date
2025-12-18
Completion Date
2030-04-03
Last Updated
2026-05-19
Healthy Volunteers
No
Interventions
ISL
ISL 2 x 1 mg oral capsules administered qw for 96 weeks
ULO
ULO 2 x 100 mg oral tablets administered qw for 96 weeks
BIC/FTC/TAF
BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
Placebo for BIC/FTC/TAF
BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
Placebo to ISL/ULO
ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
ISL/ULO
ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
Locations (55)
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, California, United States
Vivent Health ( Site 1519)
Denver, Colorado, United States
Whitman-Walker Institute ( Site 1538)
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce, Florida, United States
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, Florida, United States
Orlando Immunology Center ( Site 1501)
Orlando, Florida, United States
CAN Community Health ( Site 1510)
Sarasota, Florida, United States
Triple O Research Institute ( Site 1505)
West Palm Beach, Florida, United States
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur, Georgia, United States
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon, Georgia, United States
Henry Ford Hospital ( Site 1535)
Detroit, Michigan, United States
KC CARE Health Center ( Site 1506)
Kansas City, Missouri, United States
ID Care ( Site 1507)
Hillsborough, New Jersey, United States
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Charlotte, North Carolina, United States
Regional Center for Infectious Diseases ( Site 1516)
Greensboro, North Carolina, United States
The Ohio State University ( Site 1536)
Columbus, Ohio, United States
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia, Pennsylvania, United States
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire, Texas, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas, Texas, United States
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas, Texas, United States
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth, Texas, United States
DCOL Center for Clinical Research ( Site 1511)
Longview, Texas, United States
Harborview Medical Center ( Site 1526)
Seattle, Washington, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Caba, Buenos Aires, Argentina
Fundación Huesped ( Site 3100)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Mar del Plata, Buenos Aires, Argentina
Fundación IDEAA ( Site 3101)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto CAICI SRL ( Site 3106)
Rosario, Santa Fe Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
San Miguel de Tucumán, Tucumán Province, Argentina
Spectrum Health ( Site 3307)
Vancouver, British Columbia, Canada
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal, Quebec, Canada
Biomedica Research Group ( Site 4201)
Santiago, Region M. de Santiago, Chile
Clínica Universidad de Los Andes ( Site 4207)
Santiago, Region M. de Santiago, Chile
Espacio Eme ( Site 4202)
Santiago, Region M. de Santiago, Chile
Bordeaux University Hospital - Pellegrin ( Site 3605)
Bordeaux, Gironde, France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
Nantes, Pays de la Loire Region, France
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
Lyon, Rhone, France
Hôpital Avicenne ( Site 3602)
Bobigny, Île-de-France Region, France
Hôpital Saint-Louis ( Site 3600)
Paris, Île-de-France Region, France
Hôpital Bichat - Claude-Bernard ( Site 3601)
Paris, Île-de-France Region, France
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City, Guatemala
MEDI-K ( Site 3803)
Guatemala City, Guatemala
CELAN,S.A ( Site 3802)
Guatemala City, Guatemala
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
León, Guanajuato, Mexico
Arké SMO S.A de C.V ( Site 4505)
Veracruz, Mexico
Josha Research ( Site 4302)
Bloemfontein, Free State, South Africa
Wentworth Hospital ( Site 4303)
Durban, KwaZulu-Natal, South Africa
Be Part Yoluntu Centre ( Site 4300)
Mbekweni, Paarl, Western Cape, South Africa
Hospital Universitario La Paz ( Site 3404)
Madrid, Madrid, Comunidad de, Spain
Consorcio Hospital General Universitario de Valencia ( Site 3406)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron ( Site 3402)
Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
Barcelona, Spain
Hospital Universitario 12 de Octubre ( Site 3405)
Madrid, Spain
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
Málaga, Spain