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M9480113.TXT
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1994-08-09
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Document 0113
DOCN M9480113
TI Pharmacokinetic evaluation of the combination of zidovudine and
didanosine in children with human immunodeficiency virus infection.
DT 9410
AU Mueller BU; Pizzo PA; Farley M; Husson RN; Goldsmith J; Kovacs A; Woods
L; Ono J; Church JA; Brouwers P; et al; Pediatric Branch, National
Cancer Institute, National Institutes; of Health, Bethesda, MD 20892.
SO J Pediatr. 1994 Jul;125(1):142-6. Unique Identifier : AIDSLINE
MED/94293107
AB As part of a phase I/II trial in children infected with human
immunodeficiency virus, we studied the pharmacokinetics of zidovudine
and didanosine administered as single agents and in combination.
Zidovudine (60 to 180 mg/m2 per dose) was given orally every 6 hours,
and didanosine (60 to 180 mg/m2 per dose) every 12 hours.
Pharmacokinetic samples were obtained from 54 patients and the area
under the plasma concentration-time curve (AUC) was estimated by means
of a previously defined limited sampling strategy. Follow-up blood
samples were obtained after 4 and 12 weeks of treatment. The mean AUC
for zidovudine ranged from 4.8 mumol.hr per liter at 60 mg/m2 to 11.0
mumol.hr per liter at the 180 mg/m2 level, and increased in proportion
to the dose. The mean AUC for didanosine ranged from 2.8 mumol.hr per
liter (60 mg/m2) to 8.0 mumol.hr per liter (180 mg/m2), with a wide
interpatient variability. The AUCs of zidovudine and didanosine remained
unchanged when the agents were administered in combination. There was no
significant change in the AUCs of either drug after 4 and 12 weeks in
comparison with those on day 3 of therapy. However, there was greater
interpatient and intrapatient variability with didanosine than with
zidovudine. These observations have implications for the future utility
of therapeutic drug monitoring with these agents.
DE Adolescence Adult Child Child, Preschool Didanosine/ADMINISTRATION &
DOSAGE/*PHARMACOKINETICS/THERAPEUTIC USE Dose-Response Relationship,
Drug Drug Interactions Drug Monitoring Drug Therapy, Combination
Female Human HIV Infections/BLOOD/*DRUG THERAPY Infant Male
Zidovudine/ADMINISTRATION & DOSAGE/*PHARMACOKINETICS/THERAPEUTIC USE
CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II
JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).