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An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available MAC therapy.

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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • Disseminated MAC as defined by current (within the last month) positive blood, bone marrow, or liver biopsy culture for MAC, and considered symptomatic (fever, night sweats, anorexia, weight loss, fatigue, or malaise).
  • At least 2 months of prior treatment with available combination MAC therapy or less than 2 months of such accompanied by unacceptable adverse effects.
  • Life expectancy of more than 2 weeks.
  • Approval of eligibility from Pfizer Clinical Monitor.
  • Consent of parent or guardian if under legal age of consent.


  • Patients who have completed acute treatment with azithromycin for MAC in protocol 066-131 or 066-148 will be exempt from inclusion criteria 1 and 2 and can continue therapy through this protocol if their physician feels they have benefitted from prior azithromycin therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Known hypersensitivity or intolerance to macrolide antibiotics.
  • Inability to take oral medications or current condition that is likely to interfere with absorption (e.g., gastrectomy).

Concurrent Medication:


  • Other MAC therapy instituted during the first 2 months of the study.
  • Other investigational drugs, with the exception of those available through a Treatment IND program.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.

Prior Medication:


  • Other investigational drugs within 7 days of enrollment, with the exception of Treatment IND drugs (such as ddC).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00002089

United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340
Sponsors and Collaborators
  More Information Identifier: NCT00002089     History of Changes
Other Study ID Numbers: 058C
Study First Received: November 2, 1999
Last Updated: June 23, 2005

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

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous processed this record on May 25, 2017