TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Infectious Diseases BVBA
• Treatments: Anti-Bacterial Agents; Bedaquiline; Diarylquinolines

Criteria

Inclusion Criteria:

• Females of non-childbearing potential

• Patients with newly diagnosed sputum smear-positive pulmonary MDR-TB infection

• Patients must consent to HIV-testing

• Patients must be willing to discontinue all TB drugs to allow 7 days washout

• Patients having normal weight

• Patients are willing to be hospitalized per standard of care.

Exclusion Criteria:

• Previously having been treated for MDR-TB

• Having a significant cardiac arrhythmia that requires medication

• For HIV infected patients, having a CD4+ count < 300 cells/µL

• Patients with complicated or severe extrapulmonary manifestations of TB or neurological manifestations of TB

• Patients who will require surgical procedure for management of their TB

• Evidence of chorioretinitis, optic neuritis, or uveitis at screening

• Having had a drug susceptibility test performed prior to screening and being not susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB

• Women who are pregnant and/or breastfeeding.