Tuberculosis Clinical Trial
Official title:
A Phase II, Open-label Trial With TMC207 as Part of a Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Subjects With Sputum Smear-positive Pulmonary Infection With MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
Status | Completed |
Enrollment | 241 |
Est. completion date | January 2013 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Females of child-bearing potential must be using and are willing to continue using effective birth control methods, or be willing to practice sexual abstinence throughout treatment or be nonheterosexual active - Confirmed pulmonary MDR-TB infection including those infected with XDR (extensively drug resistant)-TB - Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (= 1+ smear-positive) - HIV-positive patients are eligible, provided they meet the requirements as described in the protocol - Must voluntarily sign the Informed Consent Form (ICF) prior to starting any study activities - Willing to comply with protocol requirements - Willing to comply with NTP treatment guidelines Exclusion Criteria: - Patients having a known or suspected hypersensitivity or serious adverse reaction to TMC207 - Patients with significant cardiac arrhythmia requiring medication - Patients with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection - Patients with certain QT/QTc interval characteristics as described in the protocol - Patients having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start - Women who are pregnant or breastfeeding - Patients who have previously received treatment with TMC207 as part of a clinical trial. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Infectious Diseases BVBA |
China, Estonia, Kenya, Korea, Republic of, Latvia, Peru, Philippines, Russian Federation, South Africa, Thailand, Turkey, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Median Time to Sputum Culture Conversion | The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube [MGIT]). | Up to Week 24 | No |
Secondary | The Percentage of Participants With Sputum Culture Conversion | The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders. | Week 120 | No |
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