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)

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.