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TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00523926
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : August 15, 2012
Information provided by:
Tibotec BVBA

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

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: TMC207 Phase 2

Detailed Description:

This is a Phase IIa, open-label, randomized trial in treatment-naïve, sputum smear-positive, subjects with pulmonary TB to assess the extended early bactericidal activity (eEBA) of TMC207. The study population will consist of 60 treatment-naive subjects with M. tuberculosis infection.

Subjects will receive orally 25 mg TMC207 po q.d. (Treatment A), 100 mg TMC207 po q.d. (Treatment B) or 400 mg TMC207 po q.d. (Treatment C) daily for 7 days. Subjects in treatment group D will receive 600 mg rifampin po q.d. daily for 7 days and subjects in treatment group E will receive 300 mg isoniazid po q.d. daily for 7 days. After 7 days, subjects in all treatment groups will receive appropriate anti-TB therapy according to national standards of country TB guidelines and culture and sensitivity results of the sputum specimens until clinical and microbiological cures have been achieved. Three once-daily dose regimens of TMC207, for 7 days, will be studied versus 2 comparator treatments, rifampin and isoniazid in the present trial.TMC207 treatment groups: 25 mg TMC207 po q.d; 100 mg. TMC207 po q.d; 400 mg TMC207 po q.d.; TMC207 will be administered as a 10 or 40 mg/mL oral solution. Comparator groups: 600 mg rifampin po q.d. administered as capsules containing 300 mg rifampin; 300 mg isoniazid po q.d. administered as tablets containing 300 mg isoniazid.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Primary Outcome Measures :
  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 Outcome Measures :
  1. Assess the short term safety, tolerability and PK of multiple oral doses of TMC207 in treatment-naïve subjects with pulmonary M.tuberculosis infection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00523926

Sponsors and Collaborators
Tibotec BVBA
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Study Director: Tibotec-Virco Virology BVBA Clinical Trial Tibotec BVBA

Publications of Results:
Layout table for additonal information Identifier: NCT00523926    
Other Study ID Numbers: CR002725
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012
Keywords provided by Tibotec BVBA:
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents