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M9460657.TXT
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1994-06-25
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Document 0657
DOCN M9460657
TI Orally administered clarithromycin for the treatment of systemic
Mycobacterium avium complex infection in children with acquired
immunodeficiency syndrome.
DT 9408
AU Husson RN; Ross LA; Sandelli S; Inderlied CB; Venzon D; Lewis LL; Woods
L; Conville PS; Witebsky FG; Pizzo PA; Pediatric Branch, National Cancer
Institute, Bethesda, Maryland.
SO J Pediatr. 1994 May;124(5 Pt 1):807-14. Unique Identifier : AIDSLINE
MED/94231388
AB OBJECTIVE: To determine the safety, tolerance, pharmacokinetics, and
antimycobacterial activity of orally administered clarithromycin in
children with acquired immunodeficiency syndrome and disseminated
Mycobacterium avium complex (MAC) infection. DESIGN: Phase I study with
a 10-day pharmacokinetic phase followed by a 12-week continuation
therapy phase. PATIENTS: Twenty-five patients with a median age of 8.3
years were enrolled. Ten were receiving zidovudine and 13 were receiving
didanosine at the time of enrollment. INTERVENTION: Clarithromycin
suspension was administered to each patient at one of three dose levels:
3.75, 7.5, and 15 mg/kg per dose every 12 hours. Clarithromycin and
antiretroviral pharmacokinetics were measured during single-drug and
concurrent-drug administration. Clinical and laboratory monitoring was
performed biweekly. MEASUREMENTS AND MAIN RESULTS: Clarithromycin was
well tolerated at all dose levels. Plasma clarithromycin concentrations
increased proportionately with increasing doses, and significant
pharmacokinetic interactions were not observed during concurrent
administration with zidovudine or didanosine. Decreases in mycobacterial
load in blood were observed only at the highest clarithromycin dose
level. Decreased susceptibility to clarithromycin developed rapidly
(within 12 to 16 weeks) in the majority of MAC strains isolated from
study patients.
DE Administration, Oral Adolescence AIDS-Related Opportunistic
Infections/*DRUG THERAPY/MICROBIOLOGY Child Child, Preschool
Clarithromycin/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE Female
Human Infant Male Microbial Sensitivity Tests *Mycobacterium avium
Complex/DRUG EFFECTS/ISOLATION & PURIF Mycobacterium
avium-intracellulare Infection/*DRUG THERAPY/ MICROBIOLOGY Recurrence
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).