Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164463
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-10
Brief Title:
TBTC Study 2728 PK Moxifloxacin Pharmacokinetics During TB Treatment
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 2728 PK Pharmacokinetic Issues in the Use of Moxifloxacin for Treatment of Tuberculosis
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This substudy of TBTC Studies 27 and 28 compares 1 the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2 the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy isoniazid or ethambutol rifampin and pyrazinamide to those of healthy volunteers receiving moxifloxacin plus rifampin It also evaluates the association between polymorphisms of MDR1 genotype P-glycoprotein and rifampin pharmacokinetic parameters the effect of polymorphisms of MDR1 genotype andor rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype NAT2 and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity cavitary lung disease Body Mass Index weight duration of study treatment prior to PK co-morbidities and C-reactive protein Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None