HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive
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.
Interventions
Sponsors
North American Biologicals Inc
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed