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: Interventional
- Study Design
- Primary Purpose: Treatment
- Masking: Double
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.
- 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
- Lead Sponsor
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