An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002090
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  Purpose

To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)

Resource links provided by NLM:


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

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Medications allowed under a Treatment IND program.

Patients must have:

  • HIV infection.
  • Disseminated Mycobacterium avium Complex.
  • Fever (> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
  • Life expectancy of at least the duration of the study.
  • Consent of parent or guardian if below the legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

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

Prior Medication:

Excluded:

  • Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
  • Any other antibiotic with known activity against M. avium within 7 days prior to study entry.

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002090

Locations
United States, Massachusetts
Beth Israel Hosp
Boston, Massachusetts, United States, 02215
United States, New York
Bronx Veterans Affairs Med Ctr
Bronx, New York, United States, 10468
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, United States, 13210
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 43210
United States, Texas
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States, 78236
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002090     History of Changes
Other Study ID Numbers: 058H, 066-148
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Mycobacterium avium-intracellulare Infection
Mycobacterium Infections
Syndrome
Actinomycetales Infections
Bacterial Infections
Disease
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections, Nontuberculous
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014