Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection

Saroj S. Bakshi, Paula Britto, Edmund Capparelli, Lynne Mofenson, Mary Glen Fowler, Suraiya Rasheed, David Schoenfeld, Bonnie Zimmer, Yitzchak Frank, Ram Yogev, Eleanor Jimenez, Miklos Salgo, Gloria Boone, Savita G. Pahwa*

*Corresponding author for this work

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

A double-blind phase II trial compared zalcitabine (0.03 mg/kg/day) in combination with zidovudine (720 mg/m2/day) and zidovudine monotherapy in 250 clinically stable, previously zidovudinetreated, human immunodeficiency virus-infected children. The combination was well-tolerated except for an increased incidence of neutropenia (14%) compared with that in children receiving monotherapy (5%). No differences were noted for time to first AIDS- defining illness or death, neuropsychologic status, or weight Z scores. In patients in the combination arm, the CD4 cell count decline was slower (13% per year) than in patients receiving monotherapy (25% per year) (P = .03), and quantitative peripheral blood mononuclear cell virus load remained lower at all time points (P = .08). Deaths were fewer in patients receiving combination therapy (4) compared with those in patients receiving monotherapy (10) (P = .083). Thus, administration of zidovudine with zalcitabine to children with prior zidovudine treatment did not result in a significant increase in toxicity compared with that resulting from zidovudine monotherapy and demonstrated improvement in immunologic and virologic surrogate markers.

Original languageEnglish (US)
Pages (from-to)1039-1050
Number of pages12
JournalJournal of Infectious Diseases
Volume175
Issue number5
DOIs
StatePublished - Jan 1 1997

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Bakshi, S. S., Britto, P., Capparelli, E., Mofenson, L., Fowler, M. G., Rasheed, S., Schoenfeld, D., Zimmer, B., Frank, Y., Yogev, R., Jimenez, E., Salgo, M., Boone, G., & Pahwa, S. G. (1997). Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. Journal of Infectious Diseases, 175(5), 1039-1050. https://doi.org/10.1086/520351