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

Inclusion Criteria16

• 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).