Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

Exclusion Criteria

• •Concurrent Medication:
• •Excluded:
• •MAC inhibitors, including aminoglycosides, quinolones, clofazimine, azithromycin (except when administered as a substitute drug), and rifamycins, during the first 24 weeks of the study.
• •Immunomodulators (including colony-stimulating cytokines such as GM-CSF and G-CSF) other than those that are specifically allowed.
• •Steroids in excess of physiologic replacement doses.
• •Cytotoxic chemotherapy.
• •Patients with the following prior conditions are excluded:
• •History of treatment-limiting intolerance or hypersensitivity to the study drugs or other macrolides.
• •Changes on chest radiograph within 7 days prior to study entry, that are consistent with acute Pneumocystis carinii pneumonia, pulmonary tuberculosis, or other acute respiratory infection.
• •Prior Medication:
• •Excluded:
• •Clarithromycin, azithromycin, or ethambutol for more than 10 consecutive days within the 8 weeks prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry.
• •Cytokines (other than erythropoietin and interferon-alpha) within 8 weeks prior to study entry.
• •Steroids within 8 weeks prior to study entry.
• •Cytotoxic chemotherapy within 8 weeks prior to study entry.
• •Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness or infection within 4 weeks prior to study entry.
• •Rifabutin monotherapy if initiated for MAC prophylaxis between the time an initial AFB positive blood sample was collected and study entry.
• •Aminoglycosides, quinolones, clofazimine, or rifamycins IF ADMINISTERED IN ANY COMBINATION within 7 days prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry.