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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Bedaquiline; Diarylquinolines

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