Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis

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).