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.

Categories

Location
Topic

Clinical Trials

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

Read More

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

A5274: REMEMBER, Reducing Early Mortality and Early...

This study is being done in people who are starting HIV treatment and who live in areas where the TB infection rate is high. The...

Read More

A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

Read More