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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

Rhonda White Community Program Manager
Anneke Hesseling Investigator
Vandana Kulkarni Laboratory Technologist
Mats Karlsson Pharmacologist
Elin Svensson Pharmacologist
Anthony Garcia-Prats Study Co-Chair
Ethel Weld Study Co-Chair
Kelly Dooley Study Vice-Chair
Renee Browning DAIDS Medical Officer
Christine Chiou DAIDS Medical Officer
Jack Moye Jr. NICHD Medical Officer

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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