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Impact of Malnutrition on Pharmacokinetic or Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in TB-HIV Co-infected Children — TB-Speed TB-PK  

Tuberculosis Clinical Trial

Official title:
Impact of Malnutrition on Pharmacokinetic or Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in TB-HIV Co-infected Children

Clinical Trial Summary

TB-Speed TB-PK is a cross-sectional PK study of anti-TB treatment nested in the TB-Speed HIV and TB-Speed SAM studies aiming at assessing the impact of malnutrition on PK of rifampicin, isoniazid, pyrazinamide, and ethambutol in TB-HIV co-infected children in Uganda and Zambia.

Clinical Trial Description

Tuberculosis can worsen malnutrition and in turn malnutrition increases the risk of TB. HIV infection is prevalent in children with TB and SAM and is often associated with poor outcomes when present. TB alone is the leading cause of death of among HIV-infected children worldwide accounting for a third of all the death in this group. In 2010, the WHO recommended increased dose for rifampicin (+50%), isoniazid (+100%), and pyrazinamide (+33%) based on PK data showing that plasma drug concentrations in children using standard adult dosages did not reach target levels. In children that are TB/HIV co-infected, drug-drug interactions between anti-TB drugs and antiretroviral drugs are of concern. The investigators hypothesize that HIV-infection and SAM, each one on its own, may have an impact on TB drugs concentrations. Furthermore, SAM is frequent in children with HIV, and may affect the metabolism of anti-TB drugs and consequently result in low serum concentration. TB-Speed TB-PK is a cross-sectional PK study of anti-TB treatment nested in the TB-Speed HIV and TB-Speed SAM studies aiming at assessing the impact of malnutrition on PK of rifampicin, isoniazid, pyrazinamide, and ethambutol in TB-HIV co-infected children. It will be implemented in Uganda and Zambia. Children will also be enrolled from routine care for TB outside of the TB- Speed HIV and TB-Speed SAM studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04972903
Study type Observational
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Aurelia Vessière, PhD
Phone +33 (0)5 57 57 15 35
Email aurelia.vessiere@u-bordeaux.fr
Status Not yet recruiting
Phase
Start date August 2021
Completion date December 2022
View Details
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