Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023387
Status:
COMPLETED
Last Update Posted:
2005-09-13
First Post:
2001-09-06
Brief Title:
TBTC Study 25PK Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Intensive Pharmacokinetic Study of Three Doses of Rifapentine 600 900 and 1200mg During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
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 compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses 600 mg 900 mg and 1200 mg
Secondary objective To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment
Secondary objective To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment
Detailed Description:
We will enroll 24-36 patients 8-12 at each dose of 600 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center CRC to allow for frequent blood sampling over a 24-hour period Otherwise patients will be evaluated in the clinic
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 |
|---|---|---|---|
| TBTC Study 25PK | None | None | None |