A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive
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.
Sites / Locations
- UAB, Dept. of Ped., Div. of Infectious Diseases
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Usc La Nichd Crs
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSF Pediatric AIDS CRS
- Univ. of Colorado Denver NICHD CRS
- Univ. of Connecticut Health Ctr., Dept. of Ped.
- Howard Univ. Washington DC NICHD CRS
- Children's National Med. Ctr., ACTU
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Children's Hospital of Michigan NICHD CRS
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- Children's Hospital at Albany Medical Center, Dept. of Peds.
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- North Shore-Long Island Jewish Health System, Dept. of Peds.
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- NYU Med. Ctr., Dept. of Medicine
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
- St. Jude/UTHSC CRS
- Children's Med. Ctr. Dallas
- Texas Children's Hosp. CRS
- UW School of Medicine - CHRMC
- San Juan City Hosp. PR NICHD CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS