A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis according to CDC guidelines. Allowed: Varicella-zoster immunoglobulin. Hepatitis B immunoglobulin. Prophylactic therapies not involving immunoglobulin. Patients must have: HIV infection. CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years). Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry. Life expectancy of at least 6 months. Prior Medication: Required: Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG. Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia). Acute illness with temperature >= 100 F and/or with IV antibiotics. Grade 3 or worse clinical toxicities. Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min. Concomitant participation in an experimental antiretroviral or HIV vaccine trial. Concurrent Medication: Excluded: IVIG. Chemotherapy for an active malignancy. MMR or rubella vaccinations. Intramuscular immunoglobulin. Patients with the following prior condition are excluded: History of severe reaction to IVIG. Prior Medication: Excluded: IVIG within the past 60 days. Chemotherapy for an active malignancy within the past year. MMR or rubella vaccinations within the past 6 months. Intramuscular immunoglobulin within the past 60 days. Ongoing drug or alcohol abuse.