A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Start Date
12/18/2025
Completion Date
4/3/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ISL
ULO
BIC/FTC/TAF
Placebo for BIC/FTC/TAF
Placebo to ISL/ULO
ISL/ULO
Conditions
Locations
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, California 90036
United States
Vivent Health ( Site 1519)
Denver, Colorado 80246
United States
Whitman-Walker Institute ( Site 1538)
Washington D.C., District of Columbia 20032
United States
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce, Florida 34982
United States
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, Florida 33055
United States
Orlando Immunology Center ( Site 1501)
Orlando, Florida 32803
United States
CAN Community Health ( Site 1510)
Sarasota, Florida 34237
United States
Triple O Research Institute ( Site 1505)
West Palm Beach, Florida 33407
United States
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur, Georgia 30033
United States
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon, Georgia 31201
United States
Rush University Medical Center-Infectious Disease ( Site 1522)
Chicago, Illinois 60612
United States
Henry Ford Hospital ( Site 1535)
Detroit, Michigan 48202
United States
KC CARE Health Center ( Site 1506)
Kansas City, Missouri 64111
United States
ID Care ( Site 1507)
Hillsborough, New Jersey 08844
United States
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Charlotte, North Carolina 28204
United States
Regional Center for Infectious Diseases ( Site 1516)
Greensboro, North Carolina 27401
United States
The Ohio State University ( Site 1536)
Columbus, Ohio 43210
United States
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia, Pennsylvania 19104
United States
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire, Texas 77401
United States
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas, Texas 75208
United States
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas, Texas 75246
United States
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth, Texas 76104
United States
DCOL Center for Clinical Research ( Site 1511)
Longview, Texas 75605
United States
Harborview Medical Center ( Site 1526)
Seattle, Washington 98104
United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Caba, Buenos Aires C1425AGC
Argentina
Fundación Huesped ( Site 3100)
CABA, Buenos Aires C1427CEA
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Mar del Plata, Buenos Aires B7600FZN
Argentina
Fundación IDEAA ( Site 3101)
Buenos Aires, Buenos Aires F.D. C1405CKC
Argentina
Instituto CAICI SRL ( Site 3106)
Rosario, Santa Fe Province S2000PBJ
Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
San Miguel de Tucumán, Tucumán Province T4000IHE
Argentina
Spectrum Health ( Site 3307)
Vancouver, British Columbia V6Z 2T1
Canada
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal, Quebec H2L 4P9
Canada
Biomedica Research Group ( Site 4201)
Santiago, Region M. de Santiago 7500710
Chile
Clínica Universidad de Los Andes ( Site 4207)
Santiago, Region M. de Santiago 7620157
Chile
Espacio Eme ( Site 4202)
Santiago, Region M. de Santiago 7770086
Chile
Bordeaux University Hospital - Pellegrin ( Site 3605)
Bordeaux, Gironde 33000
France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
Toulouse, Haute-Garonne 31059
France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
Nantes, Pays de la Loire Region 44093
France
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
Lyon, Rhone 69317
France
Hôpital Avicenne ( Site 3602)
Bobigny, Île-de-France Region 93000
France
Hôpital Saint-Louis ( Site 3600)
Paris, Île-de-France Region 75010
France
Hôpital Bichat - Claude-Bernard ( Site 3601)
Paris, Île-de-France Region 75018
France
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City, 01009
Guatemala
MEDI-K ( Site 3803)
Guatemala City, 01009
Guatemala
CELAN,S.A ( Site 3802)
Guatemala City, 01010
Guatemala
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
León, Guanajuato 37000
Mexico
Josha Research ( Site 4302)
Bloemfontein, Free State 9301
South Africa
Wentworth Hospital ( Site 4303)
Durban, KwaZulu-Natal 4052
South Africa
Be Part Yoluntu Centre ( Site 4300)
Mbekweni, Paarl, Western Cape 7646
South Africa
Hospital Universitario La Paz ( Site 3404)
Madrid, Madrid, Comunidad de 28029
Spain
Consorcio Hospital General Universitario de Valencia ( Site 3406)
Valencia, Valenciana, Comunitat 46014
Spain
Hospital Universitari Vall d'Hebron ( Site 3402)
Barcelona, 08035
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
Barcelona, 08036
Spain
Hospital Universitario 12 de Octubre ( Site 3405)
Madrid, 28041
Spain
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
Málaga, 29010
Spain