A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Recruiting · NCT07266831 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
55 locations listed across 14 US states.
- 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
- Rush University Medical Center-Infectious Disease ( Site 1522) - Chicago, Illinois, 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
- Hospital Universitari Vall d'Hebron ( Site 3402) - Barcelona, Spain
- HOSPITAL CLÍNIC DE BARCELONA ( Site 3400) - Barcelona, Spain
- 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
- Hospital Universitario 12 de Octubre ( Site 3405) - Madrid, Spain
- Complejo Hospitalario Virgen De La Victoria ( Site 3409) - Málaga, Spain
- Spectrum Health ( Site 3307) - Vancouver, British Columbia, Canada
- Fundación Huesped ( Site 3100) - CABA, Buenos Aires, Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102) - 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
- Josha Research ( Site 4302) - Bloemfontein, Free State, South Africa
- Bordeaux University Hospital - Pellegrin ( Site 3605) - Bordeaux, Gironde, France
- Morales Vargas Centro de Investigacion, S.C. ( Site 4502) - León, Guanajuato, Mexico
- Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608) - Toulouse, Haute-Garonne, France
- Wentworth Hospital ( Site 4303) - Durban, KwaZulu-Natal, South Africa
- Hospital Universitario La Paz ( Site 3404) - Madrid, Madrid, Comunidad de, Spain
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606) - Nantes, Pays de la Loire Region, France
- 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
- HOPITAL DE LA CROIX ROUSSE ( Site 3613) - Lyon, Rhone, France
- 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
- Consorcio Hospital General Universitario de Valencia ( Site 3406) - Valencia, Valenciana, Comunitat, Spain
- Be Part Yoluntu Centre ( Site 4300) - Mbekweni, Paarl, Western Cape, South Africa
- 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