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

• Status: Completed
• Trial end date: 1998-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.

Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: North American Biologicals Inc
• Treatments: Immune Sera

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.