60
Participants
Start Date
May 3, 2016
Primary Completion Date
February 11, 2027
Study Completion Date
February 11, 2027
Bedaquiline (TMC207)
Bedaquiline (TMC207) oral tablet adult formulation (containing 100 mg bedaquiline (TMC207) per tablet) administered as 400 milligram (mg), once daily, for the first 2 weeks, followed by bedaquiline 200 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 1. Cohort 2, 3 and 4 will receive an age appropriate oral tablet formulation containing 20mg bedaquiline . Bedaquiline tablet administered orally as 200 mg, once daily, for the first 2 weeks, followed by bedaquiline 100 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 2. In Cohort 3, dose of bedaquiline 8 mg/kg qd for the first 2 weeks, followed by bedaquiline 4 mg/kg times weekly (TIW) with intakes at least 2 days (48 hours) apart for 22 weeks will be administered. In cohort 4, bedaquiline (TMC207) qd for the first 2 weeks, followed by bedaquiline TIW with intakes at least 2 days (48 hours) apart for 22 weeks.
Background Regimen (BR)
Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) medications will be dosed according to World Health Organization (WHO) guidelines, National Tuberculosis Program (NTP) guidelines and current standard of care at the site.
COMPLETED
Lung Center Of The Philippines, Quezon City
RECRUITING
Sizwe Tropical Diseases Hospital, Johannesburg
COMPLETED
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine, Kiev
COMPLETED
THINK: Tuberculosis & HIV Investigative Network, Durban
RECRUITING
De La Salle Health Sciences Institute- DLSUMC, Dasmariñas
RECRUITING
Wits Health Consortium, Port Elizabeth
RECRUITING
Desmond Tutu TB Centre, Stellenboch
COMPLETED
First Moscow State Medical University n.a. I.M. Sechenov, Moscow
RECRUITING
Hospital Geral da Polana Caniço, Maputo
RECRUITING
Silang Specialists Medical Center, San Vincent Silang
TERMINATED
Makerere University Lung Institute, Kampala
Janssen Research & Development, LLC
INDUSTRY