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
Phase of Trial: Phase I/II
Latest Information Update: 11 Oct 2018
At a glance
- Drugs Delamanid (Primary)
- Indications Tuberculosis
- Focus Adverse reactions
- Acronyms IMPAACT2005
- 26 Jun 2018 Planned End Date changed from 1 Nov 2020 to 30 Nov 2021.
- 26 Jun 2018 Planned primary completion date changed from 1 Jul 2019 to 31 May 2020.
- 05 Feb 2018 Status changed from not yet recruiting to recruiting.