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

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.

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