title: Pharmacokinetics of clarithromycin extended-release (ER) tablets in patients with AIDS.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco 94110, USA. mjacobson@php.ucsf.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Jacobson
authors.forename: David P
authors.initials: DP
authors.lastname: Nicolau
authors.forename: Christina
authors.initials: C
authors.lastname: Sutherland
authors.forename: Anna
authors.initials: A
authors.lastname: Smith
authors.forename: Francesca
authors.initials: F
authors.lastname: Aweeka
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy / Q000517:prevention & control
chemical_list: D003692:Delayed-Action Preparations; D017291:Clarithromycin