Treatment of Latent TB Infection for Jailed Persons
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ClinicalTrials.gov Identifier: NCT00128206 |
Recruitment Status
:
Completed
First Posted
: August 9, 2005
Results First Posted
: December 6, 2010
Last Update Posted
: May 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Drug: Isoniazid Drug: Rifampin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 364 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Short Course Rifampin Versus INH for LTBI in Jail |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: B
isoniazid (INH) (900 mg orally) given twice weekly for 9 months
|
Drug: Isoniazid
Isoniazid 900 mg twice weekly
|
Active Comparator: A
rifampin (600 mg orally) given daily for 4 months
|
Drug: Rifampin
Rifampin 600mg once per day
|
- 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.
- Completion of Therapy [ Time Frame: course of treatment ]
- Cost Effectiveness [ Time Frame: course of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128206
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143-0608 |
Principal Investigator: | Mary C White, PhD | University of California, San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00128206 History of Changes |
Other Study ID Numbers: |
03-135 U01AI051315 ( U.S. NIH Grant/Contract ) |
First Posted: | August 9, 2005 Key Record Dates |
Results First Posted: | December 6, 2010 |
Last Update Posted: | May 14, 2013 |
Last Verified: | May 2013 |
Keywords provided by University of California, San Francisco:
LTBI, tuberculosis, rifampin, isoniazid, prisoners |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin Isoniazid Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |