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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) in Children with MDR-TB with and without HIV
Study Status
Closed to Follow Up
DAIDS Number
20721
IND Number
134,732
Clinical Trials Link
Primary Protocol Team Members
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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