The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
NCT ID: NCT00002331
Last Updated: 2015-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1994-01-31
1995-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Ethambutol hydrochloride
Clarithromycin
Clofazimine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Locations
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Kaiser Permanente Med Ctr
Los Angeles, California, United States
UCD Med Ctr
Sacramento, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Dr Margaret Fischel
Miami, Florida, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States
Beth Israel Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Dr Stephen Hauptman
Philadelphia, Pennsylvania, United States
Vanderbilt Univ School of Medicine
Nashville, Tennessee, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Dr Javier Morales
Condado San Juan, , Puerto Rico
Countries
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References
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Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.
Other Identifiers
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M93-069
Identifier Type: -
Identifier Source: secondary_id
214A
Identifier Type: -
Identifier Source: org_study_id
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