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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002101

Enrollment

450

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Keywords

Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin

Brief 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.

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

DRUGEthambutol hydrochloride

DRUGClarithromycin

DRUGRifabutin

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026