Clinical Drug Experience Knowledgebase

Criteria

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.