Treatment of Latent TB Infection for Jailed Persons

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Isoniazid; Rifampin

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.

Exclusion Criteria:

• Ineligible for either therapy regimen for any of the following reasons:

1. history of treatment-limiting reaction to isoniazid or rifamycins;

2. pregnancy or breast feeding;

3. active tuberculosis;

4. an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal;

5. bilirubin >2 times the upper limit of normal;

6. platelets <150 K/mm3;

7. 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.