Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

Inclusion Criteria

• •Body weight at screening ≥ 35 kg.
• •On a stable failing antiretroviral (ARV) regimen for \> 8 weeks before screening and willing to continue the regimen until Day 1.
• •Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.
• •Have previously changed their ARV regimen due to treatment failure.
• •ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access.
• •Able and willing to commit to taking LEN in combination with their OBR.
• •The following laboratory parameters at screening:
• •1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula.
• •2. Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3).
• •3. Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
• •4. Platelets ≥ 50 GI/L (≥ 50,000/mm\^3).
• •5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.
• •6. Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).