Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

Inclusion Criteria:

• At least 2 positive MAC sputum cultures in the last 12 months with at least oneobtained within 12 weeks prior to randomization

• Meet ATS/IDSA 2007 pulmonary disease criteria

• Adult males and females age 18 or over

• Ability to provide informed consent for the use of study drug

Exclusion Criteria:

• Any patient who is unwilling or unable to provide consent or to comply with thisprotocol

• Cavitary NTM disease

• Patients who are currently taking or within the prior 12 weeks received any of thefollowing: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC

• Current usage of inhaled amikacin, tobramycin, or gentamicin

• In the judgment of the investigator, the patient is not a candidate for observation (e.g. severe symptoms, extensive disease burden) but rather should be treated withstandard multi-drug therapy

• Prior use of clofazimine that has resulted in an allergy to clofazimine or a severeadverse reaction

• Current usage of medications associated with QT prolongation (see Appendix C forfull list of prohibited concomitant medications)

• Corrected QT (QTc) interval on electrocardiogram (ECG) > 470 ms for females or 450ms for males, calculated using Fridericia's formula60,61

• Advanced lung disease (FEV<30%)

• HIV

• Active pulmonary tuberculosis requiring treatment at screening

• Active pulmonary malignancy or chemotherapy or radiation within 1 year of screening

• Use of chronic systemic corticosteroids at doses of 15 mg/day for more than 12 weeks

• Prior lung or other solid organ transplant

• Pregnancy, or breastfeeding that will continue during treatment