Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: Phase 1/2 study

William T. Shearer, Robert J. Israel, Stuart Starr, Courtney V. Fletcher, Diane Wara, Mobeen Rathore, Joseph Church, Jaime DeVille, Terence Fenton, Bobbie Graham, Pearl Samson, Silvija Staprans, James McNamara, John Moye, Paul J. Maddon, William C. Olson

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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 log10 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.

Original languageEnglish (US)
Pages (from-to)1774-1779
Number of pages6
JournalJournal of Infectious Diseases
Volume182
Issue number6
DOIs
Publication statusPublished - Jan 1 2000

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ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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