Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Inclusion Criteria:

• Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
• Age 18 and older
• Pretreatment isolate of M. avium complex available for MIC determination
• Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
• Available for long term followup

Exclusion Criteria:

• History of macrolide or rifamycins allergy
• Laboratory evidence of mycobacterial resistance to azithromycin
• Children less than 18 years of age
• If a menstruating female, not pregnant and on adequate birth control
• HIV+ or at risk