Status:
COMPLETED
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Lead Sponsor:
Janssen Infectious Diseases BVBA
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 resistan...
Detailed Description
The trial will be conducted in 2 consecutive stages, an exploratory (investigative) stage (Stage 1) and a proof of effectiveness stage (Stage 2). During Stage 1, a panel of 50 participants will be ran...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00449644
Start Date
June 1 2007
End Date
October 1 2012
Last Update
April 29 2014
Active Locations (16)
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1
Rio de Janeiro, Brazil
2
Chennai, India
3
New Delhi, India
4
Stopinu Region, Latvia