TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
An Open-label Study to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of TMC207 in Treatment-na�ve Subjects With Sputum Smear Positive Pulmonary Tuberculosis.
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
The purpose of this study is to assess the effects of 3 different oral doses of TMC207 administered over a 7 day period on the organism that causes tuberculosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedAugust 15, 2012
August 1, 2012
August 30, 2007
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the effects of 3 doses of TMC207 administered over a 7 day period on M. tuberculosis in sputum compared to effects of treatment with standard doses of isoniazid and rifampin
Secondary Outcomes (1)
Assess the short term safety, tolerability and PK of multiple oral doses of TMC207 in treatment-naïve subjects with pulmonary M.tuberculosis infection
Interventions
Eligibility Criteria
You may qualify if:
- Treatment-naive subjects with pulmonary M. tuberculosis infection, willing to start anti-TB therapy
- Positive for acid-fast bacilli on direct smear exam of sputum specimen
- Must consent to HIV testing
- Must agree to hospital admission
You may not qualify if:
- History or presence of hepatic or GI disease that may interfere with the absorption of TMC207, isoniazid or rifampin
- Subjects who received previous anti-mycobacterial drugs for the treatment of a mycobacteria infection and subjects who have received more than 2 weeks of treatment with a fluoroquinolone
- Subjects who have received antiretroviral therapy and/or oral or I.V. anti-fungal medication w/in the last 90 days
- Subjects with sputum cultures of M. tuberculosis resistant to rifampin
- Impaired hepatic function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tibotec BVBAlead
Related Publications (1)
Rustomjee R, Diacon AH, Allen J, Venter A, Reddy C, Patientia RF, Mthiyane TC, De Marez T, van Heeswijk R, Kerstens R, Koul A, De Beule K, Donald PR, McNeeley DF. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis. Antimicrob Agents Chemother. 2008 Aug;52(8):2831-5. doi: 10.1128/AAC.01204-07. Epub 2008 May 27.
PMID: 18505852RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tibotec-Virco Virology BVBA Clinical Trial
Tibotec BVBA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2007
First Posted
September 3, 2007
Study Start
May 1, 2005
Study Completion
October 1, 2005
Last Updated
August 15, 2012
Record last verified: 2012-08