Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001047
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012

November 2, 1999
March 30, 2012
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Complete list of historical versions of study NCT00001047 on ClinicalTrials.gov Archive Site
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Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)

To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.

Interventional
Phase 3
Primary Purpose: Treatment
  • Mycobacterium Avium-intracellulare Infection
  • HIV Infections
  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
  • Drug: Clofazimine
  • Drug: Rifabutin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
August 1996
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Inclusion Criteria

Concurrent Medication:

Recommended in patients with CD4 count <= 200 cells/mm3:

  • Antiretroviral therapy.
  • PCP prophylaxis.

Allowed in all patients:

  • Isoniazid preventive therapy.

Patients must have:

  • HIV infection.
  • Evidence of disseminated MAC infection.

NOTE:

  • Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity to the study drugs.
  • Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.

Concurrent Medication:

Excluded:

  • Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
  • Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001047
CPCRA 027, 11577
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Cohn D
Study Chair: Fisher E
Study Chair: Horsburgh CR
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

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