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Pharmacokinetics of clarithromycin extended-release (ER) tablets in patients with AIDS.

AbstractBACKGROUND:
Clarithromycin is a key agent in effective antimycobacterial therapy and prophylaxis for AIDS-related disseminated Mycobacterium avium complex (dMAC) infection. Immediate-release (IR) clarithromycin tablets are dosed at 500 mg bid for these indications. A new extended-release (ER) tablet of clarithromycin has been developed and approved at a dosing interval of once every 24 hours for treatment of respiratory tract bacterial infections. However, the pharmacokinetics of clarithromycin ER in AIDS patients with or at risk for dMAC has not been previously investigated.
METHOD:
We conducted a randomized, crossover trial in which 14 AIDS patients received clarithromycin ER, 1000 mg once daily, and clarithromycin IR, 500 mg bid, each for 1 week, with pharmacokinetic sampling at the end of each week.
RESULTS:
The mean of the individual AUC ratios for clarithromycin ER vs. IR was 1.09 (90% CI, 0.94-1.24). Adverse events were no more severe or frequent with clarithromycin ER than IR.
CONCLUSION:
Clarithromycin ER is a once-daily regimen that is as well tolerated as standard bid IR clarithromycin dosing and has average bioequivalence to the IR formulation in patients with AIDS.
AuthorsMark A Jacobson, David P Nicolau, Christina Sutherland, Anna Smith, Francesca Aweeka
JournalHIV clinical trials (HIV Clin Trials) 2005 Sep-Oct Vol. 6 Issue 5 Pg. 246-53 ISSN: 1528-4336 [Print] England
PMID16306031 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Delayed-Action Preparations
  • Clarithromycin
Topics
  • Acquired Immunodeficiency Syndrome (complications)
  • Adult
  • Aged
  • Area Under Curve
  • Clarithromycin (administration & dosage, adverse effects, pharmacokinetics)
  • Cross-Over Studies
  • Delayed-Action Preparations (adverse effects, pharmacokinetics)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mycobacterium avium-intracellulare Infection (drug therapy, prevention & control)

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