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IMPAACT 2005

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

Study Status

Enrolling

Locality

Non-US

DAIDS Number

20721

IND Number

134,732

Clinical Trials Link

Summary

IMPAACT 2005 is a Phase I/II open-label, single-arm, multisite study of Delamanid (DLM) in HIV-infected and HIV-uninfected pediatric populations with multidrug-resistant tuberculosis (MDR-TB). 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.

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