Treatment of Latent TB Infection for Jailed Persons

NCT00128206 | Completed Phase 3 Results DMC

• 2 other identifiers: 03-135U01AI051315
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Tuberculosis

Keywords

LTBI, tuberculosis, rifampin, isoniazid, prisoners

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication

  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 Outcomes (2)

• Completion of Therapy

  course of treatment

• Cost Effectiveness

  course of treatment

Study Arms (2)

B

ACTIVE COMPARATOR

isoniazid (INH) (900 mg orally) given twice weekly for 9 months

Drug: Isoniazid

A

ACTIVE COMPARATOR

rifampin (600 mg orally) given daily for 4 months

Drug: Rifampin

Interventions

Isoniazid DRUG

Isoniazid 900 mg twice weekly

B

Rifampin DRUG

Rifampin 600mg once per day

A

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143-0608, United States

Location

Related Publications (1)

• White MC, Tulsky JP, Lee JR, Chen L, Goldenson J, Spetz J, Kawamura LM. Isoniazid vs. rifampin for latent tuberculosis infection in jail inmates: toxicity and adherence. J Correct Health Care. 2012 Apr;18(2):131-42. doi: 10.1177/1078345811435973. Epub 2012 Mar 14.

  PMID: 22419641 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid; Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Initial enrollment estimates were not met, from lower TB rates, increased deportation rates and fewer Jail personnel for LTBI testing. The complexity of treatment in the jail led to technical problems in the analytic plan.

Results Point of Contact

• Title: Mary White
• Organization: University of California, San Francisco

mary.white@nursing.ucsf.edu

415-476-5213

Study Officials

• Mary C White, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2005
• First Posted: August 9, 2005
• Study Start: November 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: September 1, 2009
• Last Updated: July 21, 2020
• Results First Posted: December 6, 2010

Record last verified: 2020-07

Locations

US (1)