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

Inclusion Criteria

• •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 (eg, \> 1 tablet or any other formulation a day).
• •Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening).
• •Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
• •No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
• •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 (\> 500 cells/mm3).
• •* Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
• •* Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3).
• •* Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase)
• •≤ 5 x upper limit of normal.
• •* Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).