A Randomized trial to test the effects of a short course therapy, rifampin Given daily for 4 months, as compared to isoniazid 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. Participants, followed in jail and after release, will be followed to measure three outcomes: toxicity, adherence, and cost-effectiveness.

Condition	Intervention	Phase
Tuberculosis	Drug: Isoniazid  Drug: Rifampin	Phase III

Further Study Details: 

Expected Total Enrollment:  972

The purpose of this project is to evaluate the effect of two recommended 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. 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. We 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 isoniazid (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 [1]. Participants, followed in jail and after release, will be followed to measure three outcomes: toxicity, adherence, and cost-effectiveness. This trial has clinical, behavioral, and cost components. If rifampin has acceptable toxicity, relative to INH, and acceptable adherence levels, it may be a cost effective alternative for treatment of LTBI.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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. Women of childbearing age who are on oral contraceptives will be included if they are willing to use additional methods (condom, cervical cap, diaphragm or intrauterine device) for contraception during the study.

Exclusion Criteria:

1. Ineligible for either therapy regimen due to the following reasons: a) history of treatment-limiting reaction to isoniazid or rifamycins; b) pregnancy (by serum HCG) or breast feeding; c) active tuberculosis; d) an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal; e) bilirubin 2 times the upper limit of normal; g) taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors (NNRTIs);
2. Unable to communicate in English or Spanish;
3. Unable or unwilling to provide informed consent;
4. Not in the routine level of jail security for any reason (housed in "special security" areas);
5. Any condition that, in the best judgment of the investigator, would pose a risk to the subject during the trial. Exclusion because of ALT or AST >3 times the upper limit of normal has been used as a criteria in multi-center studies of LTBI treatment [73], whereas in other studies a less stringent criteria of >5 times normal was used [21]. The San Francisco Jail and the San Francisco TB Clinic use criteria of >3 times normal as the decision point for withholding INH.

Please refer to this study by ClinicalTrials.gov identifier  NCT00128206

Mary White      (415) 476-5213 

California
      University of California, San Francisco School of Nursing, San Francisco,  California,  94143-0608,  United States; Recruiting

Study ID Numbers:  03-135
Last Updated:  August 22, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128206
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23