- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128206
Treatment of Latent TB Infection for Jailed Persons
Clinical Trial of Short Course Rifampin Versus INH for LTBI in Jail
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143-0608
- University of California San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The inclusion criteria for this study will be San Francisco Jail inmates, age 18 or older (the jail does not house juveniles) having evidence of M. tuberculosis infection by positive tuberculin skin test (a documented reactive tuberculin skin test to 0.1 mL containing 5 Tuberculin Units) who meet current national criteria for therapy for tuberculosis infection and can provide informed consent.
Exclusion Criteria:
Ineligible for either therapy regimen for any of the following reasons:
- history of treatment-limiting reaction to isoniazid or rifamycins;
- pregnancy or breast feeding;
- active tuberculosis;
- an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal;
- bilirubin >2 times the upper limit of normal;
- platelets <150 K/mm3;
- taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors (NNRTIs);
- Unable to communicate in English or Spanish;
- Unable or unwilling to provide informed consent;
- Not in the routine level of jail security for any reason (housed in "special security" areas);
- Any condition that, in the best judgment of the investigator, would pose a risk to the subject during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: B
isoniazid (INH) (900 mg orally) given twice weekly for 9 months
|
Isoniazid 900 mg twice weekly
|
Active Comparator: A
rifampin (600 mg orally) given daily for 4 months
|
Rifampin 600mg once per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication
Time Frame: up to one year
|
Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups.
On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.
|
up to one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Completion of Therapy
Time Frame: course of treatment
|
course of treatment
|
Cost Effectiveness
Time Frame: course of treatment
|
course of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mary C White, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Fatty Acid Synthesis Inhibitors
- Rifampin
- Isoniazid
Other Study ID Numbers
- 03-135 (Other Identifier: Memorial Sloan-Kettering Cancer Center)
- U01AI051315 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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