Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023452
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2001-09-06
Brief Title:
Three Months of Weekly Rifapentine and Isoniazid for M Tuberculosis Infection
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 26 Effectiveness and Tolerability of Weekly RifapentineIsoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection
Status:
COMPLETED
Status Verified Date:
2024-07
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:
PREVENT TB
Brief Summary:
Open-label multi-center Phase III clinical trial to compare the effectiveness and tolerability of a three-month 12-dose regimen of weekly rifapentine and isoniazid 3RPTINH to the effectiveness of a nine-month 270-doseregimen of daily isoniazid 9INH to prevent tuberculosis TB among high-risk tuberculin skin-test reactors including children and HIV-infected persons who require treatment of latent TB infection LTBI
Detailed Description:
The PRIMARY objective of this open-label Phase III clinical trial is to compare the effectiveness of a three-month 12-dose regimen of weekly rifapentine and isoniazid 3RPTINH to the effectiveness of a nine-month 270-dose regimen of daily isoniazid 9INH to prevent tuberculosis TB among high-risk tuberculin skin-test reactors including children and HIV-infected persons who require treatment of latent TB infection LTBI The 3RPTINH regimen will be given under direct observation and the 9INH regimen will be self-administered
SECONDARY Objectives
Compare the rates of drug discontinuation due to adverse drug reactions associated with 3RPTINH and 9INH
Compare the rates of drug discontinuation for any reason associated with 3RPTINH and 9INH
Compare the rates of any grade 3 4 or 5 drug toxicity associated with 3RPTINH and 9INH
Compare treatment completion rates of 3RPTINH and 9INH Compare the efficacy ie among persons who complete study-phase therapy of 3RPTINH and 9INH
Compare the effectiveness and tolerability of 3RPTINH and 9INH in HIV-infected persons
Compare the effectiveness and tolerability of 3RPTINH and 9INH in children 18 years old
Compare the rates of methadone withdrawal associated with 3RPTINH and 9INH among persons concomitantly receiving methadone
Describe patterns of antibiotic resistance among M tuberculosis isolates in patients who develop TB despite treatment of latent infection
Amendment of the study protocol to allow extension of enrollment to children 12 years old and HIV-infected persons
For assessment of the primary outcome development of TB a sample size of approximately 4000 persons per arm will be required To assess tolerability one of the secondary outcomes in sub-groups children less than 12 years old and HIV-infected persons a sample size of 644 per strata will be required A sample size of 8053 patients for the primary outcome was reached on February 15 2008 with expected follow-up completion time in 2010 leaving approximately 454 additional young children and 200 HIV-infected persons to be enrolled to achieve the targets of 644 for each group The additional data on tolerability in those sub-groups will available for analysis in 2013
SECONDARY Objectives
Compare the rates of drug discontinuation due to adverse drug reactions associated with 3RPTINH and 9INH
Compare the rates of drug discontinuation for any reason associated with 3RPTINH and 9INH
Compare the rates of any grade 3 4 or 5 drug toxicity associated with 3RPTINH and 9INH
Compare treatment completion rates of 3RPTINH and 9INH Compare the efficacy ie among persons who complete study-phase therapy of 3RPTINH and 9INH
Compare the effectiveness and tolerability of 3RPTINH and 9INH in HIV-infected persons
Compare the effectiveness and tolerability of 3RPTINH and 9INH in children 18 years old
Compare the rates of methadone withdrawal associated with 3RPTINH and 9INH among persons concomitantly receiving methadone
Describe patterns of antibiotic resistance among M tuberculosis isolates in patients who develop TB despite treatment of latent infection
Amendment of the study protocol to allow extension of enrollment to children 12 years old and HIV-infected persons
For assessment of the primary outcome development of TB a sample size of approximately 4000 persons per arm will be required To assess tolerability one of the secondary outcomes in sub-groups children less than 12 years old and HIV-infected persons a sample size of 644 per strata will be required A sample size of 8053 patients for the primary outcome was reached on February 15 2008 with expected follow-up completion time in 2010 leaving approximately 454 additional young children and 200 HIV-infected persons to be enrolled to achieve the targets of 644 for each group The additional data on tolerability in those sub-groups will available for analysis in 2013
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 |
|---|---|---|---|
| CDC TBTC Study 26 | OTHER | CDC TBTC | None |