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M9620493.TXT
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1996-02-26
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Document 0493
DOCN M9620493
TI Phase I evaluation of zalcitabine administered to human immunodeficiency
virus-infected children.
DT 9602
AU Chadwick EG; Nazareno LA; Nieuwenhuis TJ; Massarella JW; de Dennis SR;
Williams K; Yogev R; Department of Pediatrics, Northwestern University
Medical School,; Chicago, Illinois, USA.
SO J Infect Dis. 1995 Dec;172(6):1475-9. Unique Identifier : AIDSLINE
MED/96083490
AB The safety, tolerability, and pharmacokinetics of zalcitabine (ddC) in a
single oral dose (0.02 mg/kg) was evaluated in 23 mildly symptomatic
human immunodeficiency virus-infected children (mean age, 4.2 years).
After administration of ddC, blood samples were obtained at 0.5, 1, 1.5,
2, 4, 6, and 8 h for analysis. The drug was well tolerated and no side
effects were noted. Plasma ddC levels were determined by ion spray
liquid chromatography/tandem mass spectrometry. ddC was rapidly
absorbed, with a mean maximum plasma concentration of 9.3 ng/mL (range,
3.2-14.1) attained within a mean of 1 h (range, 0.5-2.0). Mean
elimination half-life was 1.4 h (range, 1.0-3.5), mean area under the
plasma concentration-time curve was 25 ng.h/mL (range, 11-37), and mean
total body clearance was 14.6 mL/min/kg (range, 8.9-30.6). Plasma
concentrations were lower and the half-life shorter in these children
than in adults given comparable doses, suggesting that ddC may be
cleared more rapidly in children than adults.
DE Adult Antiviral Agents/*THERAPEUTIC USE Child Child, Preschool
Female Half-Life Human HIV Infections/*DRUG THERAPY Infant Male
Support, Non-U.S. Gov't Zalcitabine/PHARMACOKINETICS/*THERAPEUTIC USE
CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).