Status:
COMPLETED
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
North American Biologicals Inc
Conditions:
HIV Infections
Eligibility:
All Genders
2-12 years
Phase:
PHASE1
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...
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 hypoth...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1998
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00000827
End Date
April 1 1998
Last Update
November 4 2021
Active Locations (39)
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1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35294
2
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
3
Usc La Nichd Crs
Los Angeles, California, United States, 90033
4
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States