Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulinin HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)

The clinical, immunologic, and virologic effects and the pharmacokinetics o f human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVI G) were assessed in 30 HIV-infected children aged 2-11 years. An had modera tely advanced disease with an immune complex-dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and seria l immunologic and virologic assays were performed. HIVIG doses as high as 8 00 mg/kg were safe and well tolerated. The half-life of HIVIG, determined b y serial p24 antibody titers, was 13-16 days, the volume of distribution wa s 102-113 mL/kg, and clearance was 5.6-6.0 mL/kg/day. Plasma ICD p24 decrea sed during the infusions, but CD4 cell levels, plasma RNA copy number, cell ular virus, immunoglobulin levels, and neutralizing antibody titers were mi nimally affected by the infusions. Clinical status did not change during th e 3-month infusion and 3-month follow-up periods.