A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 45
- Locations
- 39
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •PCP prophylaxis according to CDC guidelines.
- •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:
- •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:
- •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.