Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03800381
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-01-03
Brief Title:
Adequacy of the New Pediatric IsoniazidRifampinPyrazinamide HRZ Tablet
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacokinetics of Anti-tuberculosis and Antiretroviral Drugs in Children
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lack of quality-assured pediatric formulations of the first-line antituberculosis anti-TB drugs is barrier to optimized tuberculosis TB treatment outcome in children In 2010 and subsequently modified in 2014 the World Health Organization WHO recommended increased dosages of the first-line anti-TB drugs for children but there were no child-friendly fixed-dose combination FDC formulations based on the guidelines A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration Cmax 8 mgL and pyrazinamide Cmax 35 mgL The TB Alliance and the WHO led the development of a new child-appropriate isoniazidrifampinpyrazinamide HRZ and isoniazidrifampin HR FDC formulation in line with current WHO recommended dosing guidelines The new formulations dissolve quickly in liquid have palatable fruit flavors and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics PK of the FDC formulation in children The study team hypothesize that the new dispersible HRZ FDC tablet dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation
Detailed Description:
This study will evaluate the PK of the new pediatric HRZ FDC tablet in Ghanaian children with TB with and without HIV coinfection The new HRZ FDC dispersible tablet was designed to be child-friendly and to achieve recommended dosages for each weight-band The formulation has been rolled out in Africa without PK studies in the target population to verify that the tablets achieves adequate drug concentrations The current study will evaluate the adequacy of the formulation by examining the PK of the component drugs as well as the effect of HIV coinfection The direct PK data will be used in a population PK model and stimulations to define optimal weight-band dosages and proportions of the components of the pediatric FDC tablets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD071779-11 | NIH | None | httpsreporternihgovquickSearch5R01HD071779-11 |