       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).

