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
Study Location:
India
Topic:
Tuberculosis and HIV
Clinicaltrials.gov Link:
https://impaactnetwork.org/studies/IMPAACT2005.asp
IRB#:
IRB00133477
Coordinator:
Nishi Suryavanshi, PhD
Enrollment:
Open
Trial Period:
Ongoing
This study is currently on hold.
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
- 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
- To evaluate the safety of DLM, when added to OBR over 24 weeks of treatment
Secondary Objectives
- 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
- To evaluate the acceptability and tolerability of DLM over 24 weeks of treatment
- To assess the long-term safety of DLM over 72 weeks following treatment initiation
- To characterize the TB treatment outcomes among enrolled participants
HIV-infected and HIV-uninfected infants, children, and adolescents less than 18 years of age with confirmed or probable MDR-TB.