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

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.
 
ClinicalTrials.gov Identifier: NCT00002336
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : January 16, 2015
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Mycobacterium Avium-intracellular Infection HIV Infections Drug: Clarithromycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 1992
Actual Primary Completion Date : November 1994
Actual Study Completion Date : November 1994






Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002336


Locations
Show Show 22 study locations
Sponsors and Collaborators
Abbott

Publications:
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ClinicalTrials.gov Identifier: NCT00002336    
Other Study ID Numbers: 124A
M91-561
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: February 2009
Keywords provided by Abbott:
Mycobacterium avium-intracellular Infection
Acquired Immunodeficiency Syndrome
Clarithromycin
Additional relevant MeSH terms:
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Clarithromycin
Infection
Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors