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Recruiting Phase 2/3 NCT07266831

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Phase 2/3 – combined trial
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * Has human immunodeficiency virus type 2 (HIV-2) infection. * Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection. * Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection. * Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma. * Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
Interventions
ISL
DRUG
ULO
DRUG
BIC/FTC/TAF
DRUG
Placebo for BIC/FTC/TAF
DRUG
Placebo to ISL/ULO
DRUG
ISL/ULO
DRUG
Locations 47
Argentina (5)
Fundación IDEAA ( Site 3101)
Buenos Aires , Buenos Aires F.D.
Study Coordinator
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Caba , Buenos Aires
Study Coordinator
Fundación Huesped ( Site 3100)
CABA , Buenos Aires
Study Coordinator
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Mar del Plata , Buenos Aires
Study Coordinator
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
San Miguel de Tucumán , Tucumán Province
Study Coordinator
Canada (2)
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal , Quebec
Study Coordinator
Spectrum Health ( Site 3307)
Vancouver , British Columbia
Study Coordinator
France (7)
Hôpital Avicenne ( Site 3602)
Bobigny , Île-de-France Region
Study Coordinator
Bordeaux University Hospital - Pellegrin ( Site 3605)
Bordeaux , Gironde
Study Coordinator
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
Lyon , Rhone
Study Coordinator
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
Nantes , Pays de la Loire Region
Study Coordinator
Hôpital Saint-Louis ( Site 3600)
Paris , Île-de-France Region
Study Coordinator
Hôpital Bichat - Claude-Bernard ( Site 3601)
Paris , Île-de-France Region
Study Coordinator
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
Toulouse , Haute-Garonne
Study Coordinator
Guatemala (3)
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City
Study Coordinator
MEDI-K ( Site 3803)
Guatemala City
Study Coordinator
CELAN,S.A ( Site 3802)
Guatemala City
Study Coordinator
Mexico (2)
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
León , Guanajuato
Study Coordinator
Arké SMO S.A de C.V ( Site 4505)
Veracruz
Study Coordinator
South Africa (2)
Wentworth Hospital ( Site 4303)
Durban , KwaZulu-Natal
Study Coordinator
Be Part Yoluntu Centre ( Site 4300)
Mbekweni, Paarl , Western Cape
Study Coordinator
Spain (4)
Hospital Universitari Vall d'Hebron ( Site 3402)
Barcelona
Study Coordinator
Hospital Universitario La Paz ( Site 3404)
Madrid , Madrid, Comunidad de
Study Coordinator
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
Málaga
Study Coordinator
Consorcio Hospital General Universitario de Valencia ( Site 3406)
Valencia , Valenciana, Comunitat
Study Coordinator
United States (22)
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire , Texas
Study Coordinator
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Charlotte , North Carolina
Study Coordinator
The Ohio State University ( Site 1536)
Columbus , Ohio
Study Coordinator
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas , Texas
Study Coordinator
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas , Texas
Study Coordinator
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur , Georgia
Study Coordinator
Vivent Health ( Site 1519)
Denver , Colorado
Study Coordinator
Henry Ford Hospital ( Site 1535)
Detroit , Michigan
Study Coordinator
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth , Texas
Study Coordinator
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce , Florida
Study Coordinator
Regional Center for Infectious Diseases ( Site 1516)
Greensboro , North Carolina
Study Coordinator
ID Care ( Site 1507)
Hillsborough , New Jersey
Study Coordinator
KC CARE Health Center ( Site 1506)
Kansas City , Missouri
Study Coordinator
DCOL Center for Clinical Research ( Site 1511)
Longview , Texas
Study Coordinator
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles , California
Study Coordinator
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon , Georgia
Study Coordinator
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens , Florida
Study Coordinator
Orlando Immunology Center ( Site 1501)
Orlando , Florida
Study Coordinator
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia , Pennsylvania
Study Coordinator
CAN Community Health ( Site 1510)
Sarasota , Florida
Study Coordinator
Whitman-Walker Institute ( Site 1538)
Washington D.C. , District of Columbia
Study Coordinator
Triple O Research Institute ( Site 1505)
West Palm Beach , Florida
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.12.2025
Completion date
03.04.2030
Registry ID
NCT07266831
Source
clinicaltrials.gov
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