Last updated 45 days ago

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

75 patients around the world

Available in Argentina

Gilead Sciences

1Research sites

75Patients around the world

This study is for people with

Hiv

To 17 Years

All Gender

: Age and body weight at screening.
Cohort 1: ≥ 12 years to < 18 years weighing ≥ 35 kg.
Cohort 2: ≥ 6 years to < 12 years weighing ≥ 25 kg to < 35 kg.
Cohort 3: ≥ 2 years to < 6 years weighing ≥ 10 kg to < 25 kg.
On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily.
Documented plasma HIV-1 ribonucleic acid (RNA) levels must be < 50 copies/mL in the last 6 months prior to screening.
Plasma HIV-1 RNA levels < 50 copies/mL at screening.
No documented or suspected resistance to integrase strand transfer inhibitors.
The following laboratory parameters at screening.
Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula.
Absolute neutrophil count > 0.50 cells/L.
Hemoglobin ≥ 85 g/L.
Platelets ≥ 50 cells/L.
Hepatic transaminases ≤ 5 x upper limit of normal.
Total bilirubin ≤ 23 μmol/L and direct bilirubin ≤ 7 μmol/L.

: CD4 cell count < 200 cells/mm^3.
CD4 percentage < 20%.
Life expectancy ≤ 1 year.
An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening.
Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening.
Acute hepatitis within 30 days prior to screening.
Positive hepatitis C virus antibody with detectable HCV RNA.
Positive hepatitis B surface antigen or positive hepatitis B virus core antibody at screening.
A history of or current decompensated liver cirrhosis.
Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance.

Helios Salud S.A. Dr. Stamboulian - Sede Central - CABA

Recruiting

Perú 1515, CABA, Buenos Aires

SponsorGilead Sciences

Study typeInterventional

Conditions

Hiv

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06532656