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

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.