Last updated 22 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

From 18 Years

All Gender

: 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.

Fundación Huésped - Buenos Aires

Recruiting

Ángel Peluffo 3932, Ciudad de Buenos Aires

StudyISLEND-2

SponsorGilead Sciences

Study typeInterventional

Conditions

Hiv

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06630299