Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
Status:
Unknown status
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens
for the treatment of HIV-associated tuberculosis
Phase: Phase III trial
Population: 300 HIV positive patients with tuberculosis.
Number of Sites:Four
1. Tuberculosis Research Centre, Chennai
2. Government General Hospital, Chennai
3. Government Hospital of Thoracic Medicine, Tambaram
4. Government Rajaji Hospital, Madurai
Study Duration:36 months
Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 /
4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the
treatment of pulmonary and extrapulmonary TB in the HIV positive patients.
2. To study the relationship between stage of HIV disease and response to anti-TB treatment.
3. To study recurrences and their nature (relapse/re-infection) in detail by using RFLP
analysis.
Study Design:It is a two armed prospective randomized open label controlled clinical trial
with stratified random allocation based on CD4 count and sputum smear grade.
All enrolled patients will be treated according to the RNTCP guidelines during the intensive
phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by
smear grade, and randomly allocated either to the standard RNTCP regimen, or to an
alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).