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M9490490.TXT
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1994-09-19
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Document 0490
DOCN M9490490
TI Pharmacokinetics of zidovudine and dideoxyinosine alone and in
combination in patients with the acquired immunodeficiency syndrome.
DT 9411
AU Barry M; Howe JL; Ormesher S; Back DJ; Breckenridge AM; Bergin C;
Mulcahy F; Beeching N; Nye F; Department of Pharmacology and
Therapeutics, University of; Liverpool.
SO Br J Clin Pharmacol. 1994 May;37(5):421-6. Unique Identifier : AIDSLINE
MED/94331278
AB 1. Zidovudine (ZDV) has proved unsuccessful in controlling disease
progression over extended periods of time in patients with AIDS.
Combination of ZDV with another reverse transcriptase inhibitor,
dideoxyinosine (ddI) may improve the duration of effectiveness of
antiretroviral therapy. The aim of this study was to investigate the
possibility of a pharmacokinetic drug interaction between ZDV and ddI.
2. The pharmacokinetics of ZDV and ddI were determined in eight patients
with AIDS who were randomised to receive ZDV 250 mg orally, ddI 250 mg
orally or a combination of ZDV 250 mg plus ddI 250 mg orally on 3 study
days separated by 1 week. 3. The administration of ZDV did not
significantly alter ddI pharmacokinetics. The mean AUC was 6.8 +/- 2.0
s.d. and 7.6 +/- 2.5 s.d. mumol l-1 h and oral clearance was 2766 +/-
686 and 2660 +/- 1297 ml min-1 in the presence and absence of ZDV,
respectively. 4. In the presence of ddI the elimination half-life of ZDV
was increased significantly by 18% from 1.1 +/- 0.3 to 1.3 +/- 0.3 h (P
< 0.05) and the mean AUC increased significantly by 35% from 4.8 +/- 1.5
to 6.5 +/- 1.5 mumol l-1 h (P < 0.05). The clearance was decreased by
29% from 3518 +/- 1123 to 2505 +/- 575 ml min-1, but this difference was
not significant. The renal clearance of ZDV was not altered by ddI. 5.
Administration of ddI also resulted in a significant 22% increase in the
AUC of GZDV, from 28.5 +/- 15.7 to 34.9 +/- 12.8 mumol l-1 h (P <
0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/METABOLISM
Administration, Oral Adult Chromatography, High Pressure Liquid
Didanosine/ADMINISTRATION & DOSAGE/*PHARMACOKINETICS/THERAPEUTIC USE
Drug Interactions Drug Therapy, Combination Half-Life Human Male
Metabolic Clearance Rate Middle Age Support, Non-U.S. Gov't
Zidovudine/ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/BLOOD/
*PHARMACOKINETICS/THERAPEUTIC USE/URINE CLINICAL TRIAL JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).