Abstract 1024 Poster Session IV, Tuesday, 5/4 (poster 106)

Objective: The clinical, immunologic and virologic effects and the pharmacokinetics of HIV human hyperimmune immunoglobulin (HIV-IG) were assessed in 30 HIV-infected children aged 2-11 years with moderately advanced disease. Methods: Three groups of children each (Group I-200 mg/kg, Group II-400 mg/kg, Group III-800 mg/kg) were given six monthly infusions of HIV-IG. All were on stable antiviral regimens and had a measurable HIV p24 ICD antigen (≥70 pg/ml) at entry. Serial studies of T cell subsets, immunoglobulin levels, p 24 antigen and antibody, plasma RNA copy number, cellular infectious units, and neutralizing antibody to autologous virus were done. Results: With one exception the infusions were safe and well tolerated; one patient had decreased capillary refill and skin mottling with her fourth and sixth infusions that did not require infusion discontinuation. The half life of the HIV-IG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 ml/kg and the clearance 5.6-6.0 ml/kg/day. ICD p24 antigen fell to undetectable levels rapidly in 12 of 13 patients during the infusions but rebounded in six patients after the infusions were discontinued. CD4 levels in the three groups decreased slowly during the infusions. Plasma HIV-RNA copy number and HIV peripheral blood mononuclear cell (PBMC) quantitative culture titers showed no significant changes in the three groups during the infusions. Neutralizing antibody titers to autologous virus did not increase as a result of the infusions. Conclusion: HIV-IG used in doses as high as 800 mg/kg/month were safe and well tolerated, but had no significant effect on CD4 levels, RNA copy number, PBMC culture titer, or neutralizing antibody titers in HIV infected children. The pharmacokinetics of HIV-IG was similar to that in HIV-infected adult men and pregnant women.