Status:
COMPLETED
Treatment of Latent TB Infection for Jailed Persons
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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)...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00128206
Start Date
November 1 2004
End Date
September 1 2009
Last Update
July 21 2020
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143-0608