Phase 2
N=233
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00910871 ↗Enrolled (actual)
233
Serious AEs
20.2%
Results posted
May 2013
Primary outcome: Primary: The Median Time to Sputum Culture Conversion — 57 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TMC207 (Drug); Background Regimen (BR) for MDR-TB (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Infectious Diseases BVBA
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Median Time to Sputum Culture Conversion |
57 | — |
| SECONDARY The Percentage of Participants With Sputum Culture Conversion |
72.2 | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00910871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.