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
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
• Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
• Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3.
• Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
Locations
United States
California
Ruane Clinical Research Group, Inc. ( Site 1513)
RECRUITING
Los Angeles
Colorado
Vivent Health ( Site 1519)
RECRUITING
Denver
Washington, D.c.
Whitman-Walker Institute ( Site 1538)
RECRUITING
Washington D.c.
Florida
Midway Immunology and Research Center ( Site 1503)
RECRUITING
Ft. Pierce
CAN Community Health- Miami Gardens ( Site 1549)
RECRUITING
Miami Gardens
Orlando Immunology Center ( Site 1501)
RECRUITING
Orlando
CAN Community Health ( Site 1510)
RECRUITING
Sarasota
Triple O Research Institute ( Site 1505)
RECRUITING
West Palm Beach
Georgia
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
RECRUITING
Decatur
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
RECRUITING
Macon
Illinois
Rush University Medical Center-Infectious Disease ( Site 1522)
RECRUITING
Chicago
Michigan
Henry Ford Hospital ( Site 1535)
RECRUITING
Detroit
Missouri
KC CARE Health Center ( Site 1506)
RECRUITING
Kansas City
North Carolina
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
RECRUITING
Charlotte
Regional Center for Infectious Diseases ( Site 1516)
RECRUITING
Greensboro
New Jersey
ID Care ( Site 1507)
RECRUITING
Hillsborough
Ohio
The Ohio State University ( Site 1536)
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania Perelman School of Medicine ( Site 1508)
RECRUITING
Philadelphia
Texas
Saint Hope Foundation, Inc. ( Site 1504)
RECRUITING
Bellaire
North Texas Infectious Diseases Consultants ( Site 1500)
RECRUITING
Dallas
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
RECRUITING
Dallas
Texas Center for Infectious Disease Associates ( Site 1502)
RECRUITING
Fort Worth
DCOL Center for Clinical Research ( Site 1511)
RECRUITING
Longview
Washington
Harborview Medical Center ( Site 1526)
RECRUITING
Seattle
Other Locations
Argentina
Fundación IDEAA ( Site 3101)
RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
RECRUITING
Caba
Fundación Huesped ( Site 3100)
RECRUITING
Caba
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
RECRUITING
Mar Del Plata
Instituto CAICI SRL ( Site 3106)
RECRUITING
Rosario
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
RECRUITING
San Miguel De Tucumán
Canada
Gestion clinique médicale l'Actuel ( Site 3303)
RECRUITING
Montreal
Spectrum Health ( Site 3307)
RECRUITING
Vancouver
Chile
Biomedica Research Group ( Site 4201)
RECRUITING
Santiago
Clínica Universidad de Los Andes ( Site 4207)
RECRUITING
Santiago
Espacio Eme ( Site 4202)
RECRUITING
Santiago
France
Hôpital Avicenne ( Site 3602)
RECRUITING
Bobigny
Bordeaux University Hospital - Pellegrin ( Site 3605)
RECRUITING
Bordeaux
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
RECRUITING
Nantes
Hôpital Bichat - Claude-Bernard ( Site 3601)
RECRUITING
Paris
Hôpital Saint-Louis ( Site 3600)
RECRUITING
Paris
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
RECRUITING
Toulouse
Guatemala
CELAN,S.A ( Site 3802)
RECRUITING
Guatemala City
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
RECRUITING
Guatemala City
MEDI-K ( Site 3803)
RECRUITING
Guatemala City
Mexico
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
RECRUITING
León
Arké SMO S.A de C.V ( Site 4505)
RECRUITING
Veracruz
South Africa
Josha Research ( Site 4302)
RECRUITING
Bloemfontein
Wentworth Hospital ( Site 4303)
RECRUITING
Durban
Be Part Yoluntu Centre ( Site 4300)
RECRUITING
Mbekweni, Paarl
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron ( Site 3402)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre ( Site 3405)
RECRUITING
Madrid
Hospital Universitario La Paz ( Site 3404)
RECRUITING
Madrid
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
RECRUITING
Málaga
Consorcio Hospital General Universitario de Valencia ( Site 3406)
RECRUITING
Valencia
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2030-04-03
Participants
Target number of participants: 570
Treatments
Experimental: Phase 2: ISL + ULO
Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
Active_comparator: Phase 2: BIC/FTC/TAF
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
Experimental: Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF
ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
Active_comparator: Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO
BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC