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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)
570 patients around the world
Available in Guatemala, Argentina, United States
Merck Sharp & Dohme LLC
3Research sites
570Patients around the world
This study is for people with
Hiv
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Medi-K Cayala
Recruiting
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Hiv
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07266831
