TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
NCT ID: NCT00449644
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2007-06-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TMC207 Stage 1
TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 weeks in addition to Background Regimen (BR) for multi-drug resistant tuberculosis (MDR-TB).
TMC207
TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Placebo Stage 1
Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 weeks in addition to BR for MDR-TB.
Placebo
Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
TMC207 Stage 2
TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 22 weeks in addition to BR for MDR-TB.
TMC207
TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Placebo Stage 2
Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 22 weeks in addition to BR for MDR-TB.
Placebo
Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Interventions
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TMC207
TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
Placebo
Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients with newly diagnosed sputum smear-positive pulmonary MDR-TB infection
* Patients must consent to HIV-testing
* Patients must be willing to discontinue all TB drugs to allow 7 days washout
* Patients having normal weight
* Patients are willing to be hospitalized per standard of care.
Exclusion Criteria
* Having a significant cardiac arrhythmia that requires medication
* For HIV infected patients, having a CD4+ count \< 300 cells/µL
* Patients with complicated or severe extrapulmonary manifestations of TB or neurological manifestations of TB
* Patients who will require surgical procedure for management of their TB
* Evidence of chorioretinitis, optic neuritis, or uveitis at screening
* Having had a drug susceptibility test performed prior to screening and being not susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB
* Women who are pregnant and/or breastfeeding.
18 Years
65 Years
ALL
No
Sponsors
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Janssen Infectious Diseases BVBA
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Infectious Diseases BVBA Clinical Trial
Role: STUDY_DIRECTOR
Janssen Infectious Diseases BVBA
Locations
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Rio de Janeiro, , Brazil
Chennai, , India
New Delhi, , India
Stopinu Region, , Latvia
Lima, , Peru
Quezon City, , Philippines
Moscow, , Russia
Bethelsdorp, , South Africa
Cape Town, , South Africa
Durban, , South Africa
George, , South Africa
Klerksdorp, , South Africa
Sandringham, , South Africa
Chiang Mai, , Thailand
Nakhon, , Thailand
Nonthaburi, , Thailand
Countries
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References
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Diacon AH, Pym A, Grobusch M, Patientia R, Rustomjee R, Page-Shipp L, Pistorius C, Krause R, Bogoshi M, Churchyard G, Venter A, Allen J, Palomino JC, De Marez T, van Heeswijk RP, Lounis N, Meyvisch P, Verbeeck J, Parys W, de Beule K, Andries K, Mc Neeley DF. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med. 2009 Jun 4;360(23):2397-405. doi: 10.1056/NEJMoa0808427.
Bolhuis MS, Akkerman OW, Sturkenboom MGG, van Boven JFM, Alffenaar JC, Stevens J. Bedaquiline exposure in people with drug-resistant TB treated for diabetes: analysis of two phase 2 trials. Int J Tuberc Lung Dis. 2023 Apr 1;27(4):335-337. doi: 10.5588/ijtld.22.0581. No abstract available.
Meyvisch P, Kambili C, Andries K, Lounis N, Theeuwes M, Dannemann B, Vandebosch A, Van der Elst W, Molenberghs G, Alonso A. Evaluation of six months sputum culture conversion as a surrogate endpoint in a multidrug resistant-tuberculosis trial. PLoS One. 2018 Jul 19;13(7):e0200539. doi: 10.1371/journal.pone.0200539. eCollection 2018.
Pym AS, Diacon AH, Tang SJ, Conradie F, Danilovits M, Chuchottaworn C, Vasilyeva I, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, Van Baelen B, van Heeswijk RP, Dannemann B; TMC207-C209 Study Group. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2016 Feb;47(2):564-74. doi: 10.1183/13993003.00724-2015. Epub 2015 Dec 2.
Diacon AH, Pym A, Grobusch MP, de los Rios JM, Gotuzzo E, Vasilyeva I, Leimane V, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, De Paepe E, van Heeswijk RP, Dannemann B; TMC207-C208 Study Group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014 Aug 21;371(8):723-32. doi: 10.1056/NEJMoa1313865.
Other Identifiers
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TMC207-TIDP13-C208
Identifier Type: OTHER
Identifier Source: secondary_id
2007-004462-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR011929
Identifier Type: -
Identifier Source: org_study_id
NCT00614627
Identifier Type: -
Identifier Source: nct_alias
NCT00980265
Identifier Type: -
Identifier Source: nct_alias
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