P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

The full title of this study is: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children with MDR-TB.

This study is a clinical trial conducted under the IMPAACT Network and supported by the National Institutes of Health—specifically the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institute of Mental Health.

Kelly Dooley, MD, PhD is Protocol Chair, and Vandanna Kulkarni, MS, is Protocol Laboratory Technologist. The Indo-JHU Clinical Research Partnership is conducting this study at the BJGMC Clinical Research Site.

The study is designed to characterize the pharmacokinetics of DLM using a model-based approach, and to evaluate safety and tolerability of DLM over 24 weeks of study treatment.

Primary Objectives

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  To evaluate the PK of DLM, when added to OBR in HIV-infected and HIV-uninfected children at doses determined to most likely achieve exposures similar to those achieved in adults with 100 mg twice-daily
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  To evaluate the safety of DLM, when added to OBR over 24 weeks of treatment

Secondary Objectives

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  To assess the contribution of dose, age, HIV co-infection and/or co-treatment to the variability in DLM drug disposition, using population PK modeling
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  To evaluate the acceptability and tolerability of DLM over 24 weeks of treatment
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  To assess the long-term safety of DLM over 72 weeks following treatment initiation
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  To characterize the TB treatment outcomes among enrolled participants