The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002336
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009

November 2, 1999
February 19, 2009
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Complete list of historical versions of study NCT00002336 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3

To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.

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Interventional
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Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Mycobacterium Avium-intracellular Infection
  • HIV Infections
Drug: Clarithromycin
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Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 count <= 100 cells/mm3.
  • No evidence of MAC.
  • Life expectancy of at least 6 months.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Certain restricted drugs (details not available).

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002336
124A, M91-561
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Abbott
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Abbott
February 2009

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