Document 0276
 DOCN  M9460276
 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
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