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The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002331
First Posted: August 31, 2001
Last Update Posted: January 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
November 2, 1999
August 31, 2001
January 16, 2015
January 1994
March 1995   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002331 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
  • Mycobacterium Avium-intracellular Infection
  • HIV Infections
  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
  • Drug: Clofazimine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 1995
March 1995   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00002331
214A
M93-069
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Abbott
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Not Provided
Abbott
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP