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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacia
• Treatments: Clarithromycin; Ethambutol; Rifabutin

Criteria

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.