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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002309
  Purpose

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.


Condition Intervention
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Azithromycin

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: 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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002309

Locations
United States, California
San Diego Naval Hosp
San Diego, California, United States, 921345000
United States, North Carolina
Womack Army Med Ctr / Med Clinic
Fort Bragg, North Carolina, United States, 283075000
United States, Texas
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States, 782365300
Sponsors and Collaborators
Pfizer
  More Information

Publications:
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

Study ID Numbers: 058I, 066-155
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002309     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Azithromycin

Study placed in the following topic categories:
Bacterial Infections
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Mycobacterium Avium Complex Infection
Immunologic Deficiency Syndromes
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection
Virus Diseases
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
HIV Infections
Azithromycin
Sexually Transmitted Diseases
Mycobacterium Infections
Retroviridae Infections

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Mycobacterium Infections, Atypical
Actinomycetales Infections
Immunologic Deficiency Syndromes
Mycobacterium avium-intracellulare Infection
Virus Diseases
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
HIV Infections
Therapeutic Uses
Azithromycin
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009