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

Pharmacia & Upjohn

Status and phase: Completed; Phase 3

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Treatments: Drug: Clarithromycin; Drug: Ethambutol hydrochloride; Drug: Rifabutin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002101

048D

CS 087250-999

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.