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

Research output: Contribution to journalArticle

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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
Pages (from-to)1039-1050
Number of pages12
JournalJournal of Infectious Diseases
Volume175
Issue number5
StatePublished - May 6 1997
Externally publishedYes

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Zalcitabine
Zidovudine
Virus Diseases
Pharmacokinetics
HIV
Pediatrics
Safety
CD4 Lymphocyte Count
Neutropenia
Blood Cells
Acquired Immunodeficiency Syndrome
Biomarkers
Viruses
Weights and Measures
Incidence
Therapeutics

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. / Bakshi, Saroj S.; Britto, Paula; Capparelli, Edmund; Mofenson, Lynne; Fowler, Mary Glen; Rasheed, Suraiya; Schoenfeld, David; Zimmer, Bonnie; Frank, Yitzchak; Yogev, Ram; Jimenez, Eleanor; Salgo, Miklos; Boone, Gloria; Pahwa, Savita G.

In: Journal of Infectious Diseases, Vol. 175, No. 5, 06.05.1997, p. 1039-1050.

Research output: Contribution to journalArticle

Bakshi, SS, Britto, P, Capparelli, E, Mofenson, L, Fowler, MG, Rasheed, S, Schoenfeld, D, Zimmer, B, Frank, Y, Yogev, R, Jimenez, E, Salgo, M, Boone, G & Pahwa, SG 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, vol. 175, no. 5, pp. 1039-1050.
Bakshi, Saroj S. ; Britto, Paula ; Capparelli, Edmund ; Mofenson, Lynne ; Fowler, Mary Glen ; Rasheed, Suraiya ; Schoenfeld, David ; Zimmer, Bonnie ; Frank, Yitzchak ; Yogev, Ram ; Jimenez, Eleanor ; Salgo, Miklos ; Boone, Gloria ; Pahwa, Savita G. / Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. In: Journal of Infectious Diseases. 1997 ; Vol. 175, No. 5. pp. 1039-1050.
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