| Eligibility |
Inclusion Criteria:
- Participant has: a) multibacillary (MB) leprosy, defined as 6 or more skin lesions or
extensive confluent lesions or diffuse skin involvement, and is either borderline
lepromatous or polar lepromatous, as determined using Ridley and Jopling
classification system; and b) has a bacteriological index of >=4+ from the lesion
biopsy obtained at screening, and a bacteriological index of >= 1+ from each of 4 slit
skin smear assessments taken at screening
- Otherwise healthy on the basis of physical examination, medical history, vital signs,
and 12-lead electrocardiogram (ECG) performed at screening. If there are
abnormalities, they must be consistent with the underlying illness in the study
population. This determination must be recorded in the participant's source documents
and initialed by the investigator
- Otherwise healthy on the basis of clinical laboratory tests performed at screening. If
the results of the serum chemistry panel, including liver enzymes, other specific
tests, blood coagulation, hematology, or urinalysis are outside the normal reference
ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination must be
recorded in the participant's source documents and initialed by the investigator
- a man must agree not to donate sperm throughout treatment with TMC207 and for 3 months
after treatment is stopped
- Willing and able to adhere to the prohibitions, restrictions, and long-term follow up
requirements specified in this protocol
- If a woman is of childbearing potential, must be practising a highly effective method
of birth control (failure rate of <1% per year when used consistently and correctly)
before entry, and must also agree to use a barrier contraceptive method (that is, male
or female condom, diaphragm or cervical cap) plus spermicide. participant must also
agree to continue to use a highly effective method of contraception plus a barrier
method throughout treatment with TMC207 and until 6 months after treatment is stopped
Exclusion Criteria:
- Has experienced or is experiencing a lepra reaction requiring treatment with a
prohibited therapy
- Has a contraindication limiting the implementation of a medically accepted MB leprosy
regimen
- a) Has ever received pharmacotherapy for leprosy; b) has ever been treated with a drug
that is a component of the primary World Health Organization (WHO) regimen for the
treatment of MB leprosy (example, dapsone, rifampicin, clofazimine). Short-term (<=2
weeks) pharmacotherapy with any antibiotic that could be used as a second line
treatment for leprosy (eg, of the macrolide, quinolone, or tetracycline class) is
acceptable as long as the last administration occurred >=4 weeks before first dose of
study drug (TMC207)
- Has a concomitant infection that requires an additional systemic antimicrobial agent
- Has tuberculosis (TB), as determined by medical history and chest x-ray
- Is a woman who is pregnant, or breast-feeding, or planning to become pregnant while
enrolled in this study or within 6 months after the last dose of study drug
|
