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

Condition	Treatment or Intervention
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Azithromycin

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  058H; 066-148
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002090
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08