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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.

Gender

ALL

Eligibility 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.

Trial Officials