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| Sponsor: | Pharmacia |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002101 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Rifabutin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Efficacy Study |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
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:
Excluded within 14 days prior to study entry:
Contacts and Locations
Show 44 Study Locations
More Information
| Study ID Numbers: | 048D, CS 087250-999 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002101 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination |
Ethambutol Acquired Immunodeficiency Syndrome Clarithromycin |
|
Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Rifabutin Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Clarithromycin Gram-Positive Bacterial Infections Pathologic Processes Therapeutic Uses Retroviridae Infections Systemic Inflammatory Response Syndrome |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Bacteremia Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Antibiotics, Antitubercular Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Protein Synthesis Inhibitors Sepsis |