Overview

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.