A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Overview

To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: Double

Detailed Description

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Interventions

  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
  • Drug: Rifabutin

Participating in This Clinical Trial

Inclusion Criteria Concurrent Medication: Allowed:

  • Isoniazid for TB prophylaxis ONLY. Patients must have: – HIV infection. – MAC infection. – Life expectancy of at least 16 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: – Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded: – Antimycobacterial drugs other than the study drugs. – Carbamazepine. – Terfenadine. – Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry: – Rifabutin. – Rifampin. – Ethionamide. – Cycloserine. – Clofazimine. – Ethambutol. – Amikacin. – Ciprofloxacin. – Ofloxacin. – Sparfloxacin. – Azithromycin. – Clarithromycin. – Pyrazinamide. Excluded within 14 days prior to study entry: – Carbamazepine. – Terfenadine. – Theophylline.

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pharmacia

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