title: Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team.
abstract: The use of recombinant CD4-IgG2 in pediatric human immunodeficiency virus type 1 (HIV-1) infection was evaluated by single and multidose intravenous infusions in 18 children in a phase 1/2 study. The study drug was well tolerated, and dose proportionality was observed in terms of area under time-concentration curve and peak serum concentration. Acute decreases of >0.7 log(10) copies/mL in serum HIV-1 RNA concentration were seen in 4 of the 6 children treated with 4 weekly 10 mg/kg doses. At 14 days after treatment, 3 children had sustained reductions in serum HIV-1 RNA; the other children had rebounded to baseline levels or above. By 28 days after therapy, the peak HIV-1 cellular infectious units was reduced in all 6 children, including the 2 who had experienced an earlier transient increase in values. Thus, recombinant CD4-IgG2 treatment of HIV-1-infected children appears to be well tolerated and capable of reducing HIV-1 burden.
authors.affiliation: Dept. of Pediatrics-Allergy/Immunology, Baylor College of Medicine, Houston, TX 77030, USA. wshearer@bcm.tmc.edu
authors.forename: W T
authors.initials: WT
authors.lastname: Shearer
authors.forename: R J
authors.initials: RJ
authors.lastname: Israel
authors.forename: S
authors.initials: S
authors.lastname: Starr
authors.forename: C V
authors.initials: CV
authors.lastname: Fletcher
authors.forename: D
authors.initials: D
authors.lastname: Wara
authors.forename: M
authors.initials: M
authors.lastname: Rathore
authors.forename: J
authors.initials: J
authors.lastname: Church
authors.forename: J
authors.initials: J
authors.lastname: DeVille
authors.forename: T
authors.initials: T
authors.lastname: Fenton
authors.forename: B
authors.initials: B
authors.lastname: Graham
authors.forename: P
authors.initials: P
authors.lastname: Samson
authors.forename: S
authors.initials: S
authors.lastname: Staprans
authors.forename: J
authors.initials: J
authors.lastname: McNamara
authors.forename: J
authors.initials: J
authors.lastname: Moye
authors.forename: P J
authors.initials: PJ
authors.lastname: Maddon
authors.forename: W C
authors.initials: WC
authors.lastname: Olson
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016860:CD4 Immunoadhesins / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007262:Infusions, Intravenous; D007963:Leukocytes, Mononuclear / Q000821:virology; D008297:Male; D012367:RNA, Viral / Q000097:blood; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D016860:CD4 Immunoadhesins; C096753:CD4-IgG(2); D012367:RNA, Viral; D011993:Recombinant Fusion Proteins