Long Beach, California 90801

  • HIV Infections

Purpose:

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.


Study 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.


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.


NCT ID:

NCT00000827


Primary Contact:

Study Chair
Stiehm ER


Backup Contact:

N/A


Location Contact:

Long Beach, California 90801
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

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