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

This study has been completed.
Sponsor:
Information provided by:
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00523926
First received: August 30, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Tuberculosis
Drug: TMC207
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Tibotec BVBA:

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

Enrollment: 75
Study Start Date: May 2005
Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523926

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

Publications:
ClinicalTrials.gov Identifier: NCT00523926     History of Changes
Other Study ID Numbers: CR002725
Study First Received: August 30, 2007
Last Updated: August 14, 2012
Health Authority: USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH

Keywords provided by Tibotec BVBA:
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bedaquiline
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014