Last updated 37 days ago
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
600 patients around the world
Available in Puerto Rico, Argentina, United States
Gilead Sciences
4Research 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 week 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 ('blip'), as long as it is not confirmed on 2 consecutive visits.Plasma HIV-1 RNA levels < 50 copies/mL at screening.Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.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 (HBV) infection as determined below at the screening visit.Positive HBV surface antigen OR.Positive HBV core antibody and negative HBV surface antibody.Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.Any of the following laboratory values at screening.Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula.Alanine aminotransferase > 5 x upper limit of normal (ULN).Direct bilirubin > 1.5 x ULN.Platelets < 50,000/μL.Hemoglobin < 8.0 g/dL.
Sites
Fundación Huésped
Recruiting
Helios Salud S.A. Dr. Stamboulian - Sede Central - CABA
Recruiting
Clinical Research Puerto Rico
Recruiting
School of Medicine University of Puerto Rico-Medical Science Campus
Recruiting
StudyISLEND-1
SponsorGilead Sciences
Study typeInterventional
Conditions
Hiv
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06630286
