Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128206
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2005-08-05
Brief Title:
Treatment of Latent TB Infection for Jailed Persons
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Clinical Trial of Short Course Rifampin Versus INH for LTBI in Jail
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
The purpose of this study is to determine whether an alternative drug rifampin given daily is better at treating tuberculosis TB and more tolerable than the usual drug treatment isoniazid INH Study participants will include 972 TB infected San Francisco Jail inmates aged 18 or older One group of volunteers will take INH two times a week for 9 months and the other group will take rifampin daily for 4 months Medication will be administered in jail and at the San Francisco TB Clinic if the volunteer is released from jail prior to completing the study Participants will be seen daily for 4 months rifampin group and 2 times a week for 9 months INH group for directly observed therapy Study procedures will include 5 symptom review visits and blood samples for lab testing Follow-up will continue for each subject for five years after enrollment into the study
Detailed Description:
The purpose of this project is to evaluate the effect of two accepted regimens for treating latent tuberculosis infection LTBI in jail Tuberculosis TB in incarcerated populations continues to be a serious problem due to the large proportion of persons who are at high risk of both having latent tuberculosis infection LTBI and developing active disease Completion of treatment of LTBI while an important component of overall TB control efforts has not been successful in jails This is primarily because inmates are frequently released before finishing a 6-9 month course of standard therapy and have low rates of completing therapy in the community This study proposes to look at toxicity and adherence for this 4-month regimen compared to the nine-month regimen of to isoniazid INH and to examine costs both cost of delivered care and the cost of TB disease prevented with examination of reasons for completion or noncompletion of therapy Short-course therapies for LTBI may address this problem but they are more expensive and have not been studied adequately to answer questions about side effects completion rates and overall cost The investigators propose a randomized trial to test the effects of a short course therapy rifampin 600 mg orally given daily for 4 months as compared to INH 900 mg orally given twice weekly for 9 months Both regimens are listed by the Centers for Disease Control and Prevention CDC and the American Thoracic Society as acceptable treatments for persons with LTBI The study participants will include 972 San Francisco Jail inmates 18 years and older enrolled over a 28-month period for a sample of 486 in each study group Subjects followed in jail and after release will be followed to test three hypotheses the null hypothesis of a difference in toxicity of rifampin as compared to INH within a 95 confidence interval of 4-187 and no difference by study group in adherence and in cost-effectiveness A secondary aim is to describe reasons for completion or noncompletion of therapy Toxicity is defined as complications leading to stopping drug Adherence is defined as completion of care or 120 doses taken within 6 months for the rifampin group and 76 doses of INH taken within 12 months for the INH group Cost effectiveness will be calculated as the total cost of care nursing medical laboratory as well as facility costs and measured against costs of TB cases prevented All treatments will be administered by directly observed therapy DOT in jail and by DOT after release at the San Francisco TB Clinic Counseling on adherence going to the TB Clinic if released before completing therapy and on possible side effects will be given to all study subjects at enrollment and during follow-up clinic visits All subjects will be routinely evaluated by study personnel every two weeks for the first 6 weeks and thereafter to detect possible drug toxicity including hepatitis peripheral neuropathy arthralgias rash memory loss and other clinical symptoms All patients will undergo laboratory assessment at regular intervals according to a schedule which compares study group participation and the usual care in the jail All blood test results and new symptoms or changes in symptoms found at follow-up will be added to the jail medical record A final interview will be done with subjects at the time that they have completed or not completed this course of therapy for LTBI to determine reasons barriers and enablers Follow-up will continue for each subject for five years after enrollment into the study to measure study endpoint completion of care taken off drugs for toxicity or loss to follow-up and to measure subsequent treatment for LTBI or development of active TB by record review
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 |
|---|---|---|---|
| U01AI051315 | NIH | None | httpsreporternihgovquickSearchU01AI051315 |