- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002331
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).
SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Condado San Juan, Puerto Rico, 00907
- Dr Javier Morales
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente Med Ctr
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Sacramento, California, United States, 95817
- UCD Med Ctr
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San Francisco, California, United States, 94115
- Kaiser Permanente Med Ctr
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San Jose, California, United States, 951282699
- Santa Clara Valley Med Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
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Florida
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Miami, Florida, United States, 33136
- Dr Margaret Fischel
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Tampa, Florida, United States, 33614
- Saint Joseph's Hosp / Infectious Disease Rsch Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Louisiana
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New Orleans, Louisiana, United States, 701122699
- Tulane Univ Med School
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Univ School of Medicine
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New York
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Dr Stephen Hauptman
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt Univ School of Medicine
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Texas
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Dallas, Texas, United States, 75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Houston, Texas, United States, 77030
- Houston Veterans Administration Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- History of HIV seropositivity.
- Disseminated MAC.
- Positive blood culture for MAC within 4 weeks prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- Ability to complete the study.
NOTE:
- Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
- Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
- Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
- Amikacin.
- Azithromycin.
- Capreomycin.
- Ciprofloxacin.
- Cycloserine.
- Ethionamide.
- Gentamicin.
- Kanamycin.
- Levofloxacin.
- Lomefloxacin.
- Ofloxacin.
- Rifampin.
- Rifabutin.
- Sparfloxacin.
- Streptomycin.
- Any other aminoglycosides, quinolones, and macrolides.
Patients with the following prior conditions are excluded:
History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
Prior Medication:
Excluded:
- Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
- Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Mycobacterium avium-intracellulare Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Antitubercular Agents
- Clarithromycin
- Ethambutol
- Clofazimine
Other Study ID Numbers
- 214A
- M93-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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