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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000827

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Expected to finish

1998-04-01

Last updated by the study team

2021-11-04

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Univ. of Connecticut Health Ctr., Dept. of Ped. — Farmington, Connecticut, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• St. Joseph's Hosp. & Med. Ctr. of New Jersey — Paterson, New Jersey, United States
• Children's Hospital at Albany Medical Center, Dept. of Peds. — Albany, New York, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• North Shore-Long Island Jewish Health System, Dept. of Peds. — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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