Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023400
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2001-09-06
Brief Title:
TBTC Study 23BIntensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 23BIntensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With 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 Objective
To define the impact of nelfinavir given at 1250mg bid as part of a combination antiretroviral regimen on peak levels and area under the curve for rifabutin and the rifabutin metabolite 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy
Secondary Objectives
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin
To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis
To define detailed pharmacokinetics of isoniazid given at 15mgkg or 900 mg in patients with HIV-related tuberculosis
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies
To define the impact of nelfinavir given at 1250mg bid as part of a combination antiretroviral regimen on peak levels and area under the curve for rifabutin and the rifabutin metabolite 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy
Secondary Objectives
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin
To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis
To define detailed pharmacokinetics of isoniazid given at 15mgkg or 900 mg in patients with HIV-related tuberculosis
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23B | None | None | None |