Last updated 9 days ago
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
600 patients around the world
Available in Puerto Rico, Argentina
Gilead Sciences
1Research sites
600Patients around the world
This study is for people with
Hiv
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by.One HIV-1 RNA < 50 copies/mL immediately preceding the 24 weeks period prior to screening.Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL.During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable as long as it is not confirmed on 2 consecutive visits.Plasma HIV-1 RNA levels < 50 copies/mL at screening.Are receiving guideline-recommended standard of care treatment such as International Antiviral Society, Department of Health and Human Services, European AIDS Clinical Society consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
- Prior virologic failure.Prior use of, or exposure to, ISL or LEN.Active, serious infections requiring parenteral therapy within 30 days before randomization.Active tuberculosis infection.Acute hepatitis within 30 days before randomization.Hepatitis B virus infection, as determined below at the screening visit.Positive HBV surface antigen OR positive HBV core antibody and negative HBV surface antibody.Individuals found to be susceptible to HBV infection should be recommended to receive HBV vaccination.Active hepatitis C virus coinfection, defined as detectable HCV RNA. Individuals with prior/inactive HCV infection may be enrolled.Any of the following laboratory values at screening.Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula.Alanine aminotransferase (ALT) > 5 x upper limit of normal.Direct bilirubin > 1.5 x upper limit of normal.Platelets < 50,000/μL.Hemoglobin < 8.0 g/dL.Other protocol defined Inclusion/Exclusion criteria may apply.
Sites
Fundación Huésped - Buenos Aires
Recruiting
StudyISLEND-2
SponsorGilead Sciences
Study typeInterventional
Conditions
Hiv
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06630299
