Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023426
Status:
COMPLETED
Last Update Posted:
2005-09-13
First Post:
2001-09-06
Brief Title:
TBTC Study 25 Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 25A Prospective Randomized Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
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:
Randomized double-blind study of the tolerability of three different doses of rifapentine
Detailed Description:
Prospective randomized double-blinded comparative study Patients are randomized at the completion of induction phase therapy Sample-size is 50 HIV-seronegative patients with culture-positive drug susceptible TB in each treatment arm The first 75 patients will be randomized 21 to 900 mg600 mg rifapentine The second 75 patients will be randomized 21 to 1200 mg600 mg rifapentine The DSMB will review tolerability and safety data on the first 21 patients enrolled at the 900 mg and 600 mg doses and approve proceeding to enrollment at the 1200 mg dose
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 |
|---|---|---|---|
| 25 | None | None | None |
| HCK45 | None | None | None |