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A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002309
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
A Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex Disease in HIV-Infected People
To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count < 100 cells/mm3.
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Interventional
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Masking: Double
Primary Purpose: Treatment
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Drug: Azithromycin
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Oldfield EC, Dickinson G, Chung R, Wallace MR, Craig DB, Fessel WJ, Joyce MP, Mckee KT, Melcher G, Wagner KF, Williams WJ, Zajdowicz M, Heifits L, Dunne MW, Berman J. Once weekly azithromycin for the prevention of Mycobacterium avium complex (MAC) infection in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90

*   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

Concurrent Medication:

Required:

  • Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine).

Allowed:

  • Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).

Patients must have:

  • HIV infection.
  • CD4 count < 100 cells/mm3.
  • No MAC positive blood cultures within 1 month prior to study entry.
  • No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Positive PPD within 3 months prior to study entry (negative PPD defined as < 5 mm induration).
  • Chest x-ray suggestive of any active disease, in particular tuberculosis.
  • Known hypersensitivity to macrolide antibiotics.
  • Any other acute clinical condition likely to interfere with completion of the protocol.
  • Inability to care for self without considerable assistance and medical care.

Concurrent Medication:

Excluded:

  • Other investigational new drugs (except for foscarnet or ddC) unless prior agreement has been reached between the investigator and the Pfizer project physician.
  • Concomitant putative immunostimulants.

Patients with the following prior conditions are excluded:

History of MAC or Mycobacterium tuberculosis (MTb) infection.

Prior Medication:

Excluded within the past 4 weeks:

  • Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against MAC.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002309
058I
066-155
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Pfizer
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NIH AIDS Clinical Trials Information Service
April 1996

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