Phase
Condition
Hiv
Lung Disease
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 must begreater than or equal to (>=) 37 weeks gestation at baseline
Participant must weigh >3 kilogram (kg) at entry 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 may be used instead of BMI for age according to the localstandard of care
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 baseline or havestarted an MDR-TB treatment within 12 weeks of baseline and are willing to modify itif necessary 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
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 tested positive for Human Immunodeficiency Virus (HIV) for the firsttime at screening. In addition, participants aged <2 years and participants who arebeing breastfed or were breastfed within the last 8 weeks before screening will beexcluded if the mother has tested positive for HIV
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 ahistory of risk factors for Torsade de Pointes, example heart failure, hypokalemia,known personal or family history of Long QT Syndrome, and untreated hypothyroidism
Study Design
Study Description
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
De La Salle Health Sciences Institute- DLSUMC
Dasmarinas, 4114
PhilippinesActive - Recruiting
Lung Center Of The Philippines
Quezon City, 1100
PhilippinesCompleted
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, 119991
Russian FederationCompleted
THINK: Tuberculosis & HIV Investigative Network
Durban, 4001
South AfricaActive - Recruiting
Sizwe Tropical Diseases Hospital
Johannesburg, 2131
South AfricaActive - Recruiting
Wits Health Consortium
Port Elizabeth, 6200
South AfricaActive - Recruiting
Desmond Tutu TB Centre
Stellenboch, 7600
South AfricaActive - Recruiting
Makerere University Lung Institute
Kampala,
UgandaTerminated
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kiev, 3038
UkraineCompleted
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