Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in HIV-Infected and HIV-Uninfected Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV Infections
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 18 years
- Gender
- Both males and females
Description
This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in combination with an optimized background multidrug-resistant tuberculosis (MDR-TB) treatment regimen in HIV-infected and HIV-uninfected infants, children, and adolescents. The study ...
This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in combination with an optimized background multidrug-resistant tuberculosis (MDR-TB) treatment regimen in HIV-infected and HIV-uninfected infants, children, and adolescents. The study will enroll HIV-infected and HIV-uninfected children 0 to 18 years of age treated for clinically diagnosed or confirmed intrathoracic (pulmonary) MDR-TB and certain types of extrathoracic MDR-TB. Participants will be assigned to cohorts based on age. Cohort 1 will include children 6 years of age or older but less than 18 years of age; Cohort 2 will include children 2 years of age or older but less than 6 years of age; and Cohort 3 will include children 0 months of age and older but less than 2 years of age. Cohort 1 will be divided into two weight bands, one for participants weighing 15 kg or more but less than 30 kg and one for participants weighing 30 kg or more. Cohorts 2 and 3 will include participants weighing 3 to 30 kg. Study visits will occur at enrollment (Day 0) and at Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 96, and 120. Participants in each cohort will take BDQ once a day during the first 2 weeks. For the next 22 weeks, BDQ will be taken three times a week. Dosing for Cohorts 2 and 3 is based on data from Cohort 1. Study visits may include physical examinations, blood and urine collection, an electrocardiogram (ECG), medical history reviews, and other assessments.
Tracking Information
- NCT #
- NCT02906007
- Collaborators
- Not Provided
- Investigators
- Study Chair: Anneke Hesseling, M.D., Ph.D. Desmond Tutu TB Centre, Stellenbosch University
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