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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Anti-HIV Immune Serum Globulin (Human)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anti-HIV Immune Serum Globulin (Human)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive