Study Title: IMPAACT 2005 - Phase I/II Open-label, Single-Arm Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of Delamanid (DLM) in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug Resistance-Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB

Study Objectives

Primary Objectives 

  • To evaluate the Pharmacokinetics (PK) of Delamanid (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.

Study Design: This is a Phase I/II open-label, single-arm, PK and safety study. The study will involve four age cohorts (based on age at enrollment): 

  1. Cohort 1: Ages 12 to <18 years: adult formulation.
  2. Cohort 2: Ages 6 to <12 years: adult formulation.
  3. Cohort 3: Ages 3 to <6 years: pediatric formulation.
  4. Cohort 4: Ages 0 to <3 years: pediatric formulation.

Study Population

  • Globally: approximately 48 subjects.
  • Botswana: approximately 12 subjects to be enrolled (Gaborone and Molepolole).

The participants are HIV-infected and HIV-uninfected infants, children, and adolescents less than 18 years of age with confirmed or probable MDR-TB.

Study Status: Currently On-Hold, Ongoing 

Study Duration: 3.5 years

Sponsor

  • National Institute of Allergy and Infectious Diseases (NIAID).
  • The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).