CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 364 enrolled
Drug / intervention
Isoniazid +1 moredrug
Likely dose
Rifampin 600 mg once daily or Isoniazid 900 mg twice weeklyAI-extracted
Key inclusion· 5
  • San Francisco Jail inmate
  • Age 18 or older
  • Positive tuberculin skin test (TST ≥5 TU)
  • Meets current national criteria for therapy for tuberculosis infection
Key exclusion· 9
  • History of treatment-limiting reaction to isoniazid or rifamycins
  • Pregnancy or breast feeding
  • Active tuberculosis
  • AST or ALT >3 times upper limit of normal

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00128206
NCT00128206Phase 3Completed

Clinical Trial of Short Course Rifampin Versus INH for LTBI in Jail

University of California, San Francisco·interventional·Posted Aug 9, 2005·Updated Jul 21, 2020

In Brief

A Phase 3 clinical trial evaluating Isoniazid and Rifampin for Tuberculosis. Completed, enrolled 364 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesUnited States

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2005
Enrollment StartNov 1, 2004
Primary CompletionOct 1, 2008
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.9 years ago

Interventions

Isoniaziddrug

Isoniazid 900 mg twice weekly

Rifampindrug

Rifampin 600mg once per day