title: Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273).
abstract: The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex-dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6-6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.
authors.affiliation: UCLA Children's Hospital, Los Angeles, CA 90095, USA. estiehm@mednet. ucla.edu
authors.forename: E R
authors.initials: ER
authors.lastname: Stiehm
authors.forename: C V
authors.initials: CV
authors.lastname: Fletcher
authors.forename: L M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: P E
authors.initials: PE
authors.lastname: Palumbo
authors.forename: M
authors.initials: M
authors.lastname: Kang
authors.forename: T
authors.initials: T
authors.lastname: Fenton
authors.forename: C V
authors.initials: CV
authors.lastname: Sapan
authors.forename: W A
authors.initials: WA
authors.lastname: Meyer
authors.forename: W T
authors.initials: WT
authors.lastname: Shearer
authors.forename: E
authors.initials: E
authors.lastname: Hawkins
authors.forename: M G
authors.initials: MG
authors.lastname: Fowler
authors.forename: P
authors.initials: P
authors.lastname: Bouquin
authors.forename: L
authors.initials: L
authors.lastname: Purdue
authors.forename: E M
authors.initials: EM
authors.lastname: Sloand
authors.forename: G J
authors.initials: GJ
authors.lastname: Nemo
authors.forename: D
authors.initials: D
authors.lastname: Wara
authors.forename: Y J
authors.initials: YJ
authors.lastname: Bryson
authors.forename: S E
authors.initials: SE
authors.lastname: Starr
authors.forename: A
authors.initials: A
authors.lastname: Petru
authors.forename: S
authors.initials: S
authors.lastname: Burchett
mesh_terms: D002478:Cells, Cultured; D002648:Child; D002675:Child, Preschool; D005260:Female; D015483:HIV Antibodies / Q000276:immunology*; D016655:HIV Core Protein p24 / Q000097:blood; D015658:HIV Infections / Q000276:immunology / Q000628:therapy* / Q000821:virology; D015497:HIV-1 / Q000276:immunology / Q000502:physiology*; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007963:Leukocytes, Mononuclear; D018655:Lymphocyte Count; D008297:Male; D009500:Neutralization Tests; D012367:RNA, Viral / Q000097:blood; D016176:T-Lymphocyte Subsets / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; C084715:HIV hyperimmune globulin; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; D012367:RNA, Viral