Lamprene Multiple Patient Program

Inclusion Criteria:

1. Male or female patients 18 years of age or older
2. Written informed consent must be obtained before any project specific assessment isperformed.
3. Patients previously diagnosed with NTM infection with local or disseminatedinfection(i.e. patients with any NTM species at any site of infection)
4. Patients who failed or are intolerant of prior therapies or who have baselinemacrolide resistance or for whom an appropriate regimen cannot otherwise be devised
5. Male patients (including vasectomized patients) who agree to use a condom duringintercourse while taking clofazimine treatment and for at least 4 months afterstopping treatment with clofazimine
6. Female patients of child-bearing potential with negative pregnancy test beforeclofazimine treatment initiation and who confirm no intention to become pregnantduring the treatment with clofazimine, by using highly effective methods ofcontraception (methods that result in less than 1% pregnancy rates) while takingclofazimine treatment and for at least 4 months after stopping treatment withclofazimine

Exclusion Criteria:

1. History of hypersensitivity to any drugs or metabolites of similar chemical classes asclofazimine
2. History or current diagnosis of clinically significant ECG abnormalities that pose asafety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without apacemaker)
3. History or additional risk factors for Torsades de Pointes such as heart failure,clinically relevant hypokalemia, familial long QT syndrome or known family history ofTorsades de Pointes
4. Confirmed demonstration of resting QTcF >500 msec at screening
5. Any condition (social, psychiatric, or medical) which in the opinion of the treatingphysician would make participation in this MPP unsafe
6. Unable to swallow capsules
7. HIV-infected patients with disseminated NTM infection
8. Life expectancy less than 6 months
9. Pregnant or nursing (lactating) females