NCT03141060

Evaluating 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

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 Children With MDR-TB With and Without HIV

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected children with MDR-TB.

Detailed description

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of the anti-TB drug DLM in combination with OBR for MDR-TB in HIV-infected and HIV-uninfected children with MDR-TB. Participants will be enrolled in one of four age cohorts: 12 to less than 18 years, 6 to less than 12 years, 3 to less than 6 years, or 0 to less than 3 years. All participants will receive DLM dosed according to their age group and weight for 24 weeks. Study visits will occur at study entry; Weeks 2 and 4; every 4 weeks through Week 40; and at Weeks 48, 60, 72, and 96. Visits may include physical examinations; blood, urine, and sputum collection; chest x-rays; electrocardiograms (ECGs); hearing tests; adherence assessments; and acceptability questionnaires.

Conditions

• Tuberculosis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Delamanid	Administered orally; dosing will be based on participants' age and weight.
DRUG	Optimized multidrug background regimen (OBR) for children with MDR-TB	Non-study prescribed OBR will vary according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.

Timeline

• Start date: 2018-01-30
• Primary completion: 2025-04-22
• Completion: 2025-05-29
• First posted: 2017-05-04
• Last updated: 2025-06-10

Locations

5 sites across 3 countries: India, South Africa, Tanzania

Regulatory

• FDA-regulated drug study