Phase
Condition
Lung Disease
Hiv
Treatment
Background Regimen (BR)
Bedaquiline (TMC207)
Clinical Study ID
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be a boy or girl, aged from birth (0 months) to less than (<) 18years at screening. Participants in Cohort 4 who are <6 months of age at screening,gestational age at birth had to be greater than or equal to (>=) 37 weeks
Participant must weigh >3 kilogram (kg) at baseline and be within the 5th and 95thpercentiles (inclusive) for the participant's age, based on the World HealthOrganization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height/length may be used instead of BMI for age according tothe local standard of care. Per WHO guidance, for participants aged < 2 years inCohort 4, length will be used to calculate the BMI instead of height
For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are ofnon-childbearing potential, or if they are using effective birth control methods andare willing to continue practicing birth control methods throughout MultidrugResistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207treatment, or if they are non-heterosexually active or willing to practice sexualabstinence throughout MDR-TB treatment
For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead topregnancy of the female partner must use at minimum a male condom throughout MDR-TBtreatment and for 3 months after stopping TMC207 treatment
Participant must have confirmed or probable (clinically diagnosed or presumed)pulmonary and/or non-severe extrapulmonary MDR-TB, including pre-extensivelydrug-resistant TB (pre- extensively drug resistant [XDR]-TB) or XDR-TB infection,based on the case definitions of pediatric pulmonary and non-severe extrapulmonaryTB as described in the International (WHO) guidelines and in accordance with thelocal standard of care
Participants must be starting the initial MDR-TB treatment at Day 1 or have startedan MDR-TB treatment within 12 weeks of Day 1 and are willing to modify it ifnecessary to an acceptable MDR-TB regimen for use with TMC207
Participant must be willing to permanently discontinue RMP from at least 7 daysbefore the baseline visit
Participant or legally acceptable representative must consent/assent to humanImmunodeficiency virus (HIV) testing of the participant. The mother must alsoconsent to testing of her own HIV status, if the potential participant is a childaged <2 years, or if the participant is >= 2 years old and being breastfed or wasbreastfed within the last 8 weeks before screening, unless the mother had HIV testperformed within 1 month prior to screening and documentation of HIV status can beprovided. When documented HIV-positive status is available prior to screening forparticipants in Cohort 4 or their mother, HIV testing for the participant and motheris not required
Exclusion
Exclusion Criteria:
Participant has a clinically significant active medical condition or the presence ofany concomitant severe illness or rapidly deteriorating health condition, includingimmune deficiency (except HIV infection), which in the opinion of the investigatorwould prevent appropriate participation in the study, or that would makeimplementation of the protocol or interpretation of the study results difficult, orotherwise make the subject a poor candidate for a clinical study
Participant is a girl who is pregnant, or breast-feeding, or planning to becomepregnant while enrolled in this study or within 6 months after stopping TMC207treatment
Participant has known or presumed forms of extrapulmonary TB, other than:Lymphadenopathy (peripheral nodes or isolated mediastinal mass without significantairway compression); Pleural effusion or pleural fibrotic lesions
Participant has a significant cardiac arrhythmia that requires medication or riskfactors for Torsade de Pointes, example heart failure, hypokalemia, known personalor family history of Long QT Syndrome, and untreated hypothyroidism
Study Design
Connect with a study center
B. J. Medical College & Civil Hospital
Ahmedabad, 380 016
IndiaSite Not Available
National Institute for Research in Tuberculosis (NIRT)
Chennai, 600 031
IndiaSite Not Available
National Institute of Tuberculosis and Respiratory Diseases (NITRD)
New Delhi, 110 030
IndiaSite Not Available
Hospital Geral da Polana Caniço
Maputo, 00000
MozambiqueActive - Recruiting
Hospital Geral da Polana Caniço
Maputo 1040652, 00000
MozambiqueSite Not Available
De La Salle Health Sciences Institute- DLSUMC
Dasmarinas, 4114
PhilippinesSite Not Available
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, 4114
PhilippinesActive - Recruiting
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas 1715430, 4114
PhilippinesSite Not Available
Lung Center Of The Philippines
Quezon City, 1100
PhilippinesCompleted
Lung Center Of The Philippines
Quezon City 1692192, 1100
PhilippinesSite Not Available
Silang Specialists Medical Center
San Vincent Silang, 000
PhilippinesActive - Recruiting
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, 119991
RussiaCompleted
First Moscow State Medical University n.a. I.M. Sechenov
Moscow 524901, 119991
RussiaSite Not Available
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, 119991
Russian FederationSite Not Available
THINK: Tuberculosis & HIV Investigative Network
Durban, 4001
South AfricaCompleted
THINK: Tuberculosis & HIV Investigative Network
Durban 1007311, 4001
South AfricaSite Not Available
Sizwe Tropical Diseases Hospital
Johannesburg, 2131
South AfricaActive - Recruiting
Sizwe Tropical Diseases Hospital
Johannesburg 993800, 2131
South AfricaSite Not Available
Wits Health Consortium
Port Elizabeth, 6200
South AfricaActive - Recruiting
Wits Health Consortium
Port Elizabeth 964420, 6200
South AfricaSite Not Available
Desmond Tutu TB Centre
Stellenboch, 7600
South AfricaActive - Recruiting
Makerere University Lung Institute
Kampala,
UgandaTerminated
Makerere University Lung Institute
Kampala 232422,
UgandaSite Not Available
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kiev, 3038
UkraineCompleted
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kiev 703448, 3038
UkraineSite Not Available

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