Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023348
Status:
COMPLETED
Last Update Posted:
2005-09-13
First Post:
2001-09-06
Brief Title:
TBTC Study 23A Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 23A Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23 Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin
Secondary Objectives
1 To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin
2 To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy
3 To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy
4 To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial
1 To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin
Secondary Objectives
1 To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin
2 To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy
3 To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy
4 To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial
Detailed Description:
This study will seek to enroll every eligible patient enrolled in TBTC Study 23 Consenting patients will be asked to undergo measurements of isoniazid if receiving rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved at least two weeks following the start of rifabutin
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23A | None | None | None |