None listed
Conditions
Interventions
TMC207 Type of group
TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks in addition to Background Regimen (BR) for the treatment of multi-drug resistant tuberculosis (MDR-TB).
Sponsors
Janssen Infectious Diseases - Diagnostics BVBA,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Subjects men or women at least 18 years of age. Women can participate if they are not potentially fertile, if they are using effective birth control methods and are willing to continue using birth control methods in accordance with Section 5.2.4 throughout the treatment for MDR-TB, or without are not heterosexually active or are willing to practice sexual abstinence throughout the treatment for MDR-TB. • Confirmed MDR-TB pulmonary infection, which is defined as an infection by a strain of M. tuberculosis resistant to at least RMP and INH proven by a previous analysis carried out in a center for the treatment of TB within the previous six months. Subjects infected with XDR-TB may also enter the study. • Positive for acid-resistant bacilli (AFB) on direct smear examination of the expectorated sputum sample (> 1 + positive smear). • HIV positive or negative status documented in the selection or within the month prior to the start of the study (by means of enzymatic immunoabsorption tests [ELISA] and / or Western Blot). • Subjects who have signed the ICF voluntarily before the first activity related to the study. • Subjects who can meet the requirements of the protocol. • Subjects willing to comply with the NTP treatment guidelines.
Exclusion criteria
Exclusion criteria: • Subjects having a known or suspected hypersensitivity or serious adverse reaction to TMC207. • Subjects using disallowed concomitant therapy as specified in Protocol Section 5.3.11. • Subjects having a current or past history of alcohol and/or drug use that, in the investigator´s opinion, would compromise the subject´s safety or compliance to the study protocol procedures. • HIV infected subjects having a CD4+ count 450 ms at screening; b. A history of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of Long QT Syndrome; c. The use of concomitant medications that prolong the QT/QTc interval listed as disallowed medication in Protocol Section 5.3.11; d. Pathological Q-waves (defined as > 40 ms or depth > 0.4-0.5 mV); e. Evidence of ventricular pre-excitation; f. ECG evidence of complete or incomplete left bundle branch block or right bundle branch block; g. Evidence of second or third degree heart block; h. Intraventricular conduction delay with QRS duration > 120 ms; i. Bradycardia as defined by sinus rate 1.5 times upper limit of normal [ULN]); - Lipase grade 3 or greater (> 2.0 x ULN); - Hemoglobin grade 4 ( 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Alanine aminotransferase (ALT) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Alkaline phosphatase (ALP) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Total bilirubin grade 3 or greater (> 2.00 x ULN, or > 1.50 x ULN when accompanied by any increase in other liver function test) to be excluded, grade 2 (> 1.50 x ULN, or > 1.25 x ULN when accompanied by any increase in other liver function test) must be discussed with the Medical Leader; • Women who are pregnant or breastfeeding. • Subjects who have previously received treatment with TMC207 as part of a clinical trial. • Subjects having AIDS defining illnesses other than TB, or showing severe symptoms of HIV infection that would make the subject a poor candidate for participation in the trial. • Subjects who, upon the evaluation of their pulmonary disease, will require surgical procedure for management of their TB infection within the 24-week treatment period with TMC207.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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]). Measure:The Median Time to Sputum Culture Conversion Timepoints:Up to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:The Percentage of Participants With Sputum Culture Conversion Timepoints:Week 120 | — |
Countries
Argentina, Brazil, China, Estonia, Hong Kong, India, Korea South, Latovia, Peru, Philippines, Russian Federation, South Africa, Thailand, Turkey, Ukraine, Vietnam
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed