Preventive Therapy for Tuberculosis in HIV Infected Persons
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis
in HIV infected persons
Phase: Phase III trial
Population: 650 HIV positive patients without tuberculosis
Number of sites: Three
1. Tuberculosis Research centre, Chennai
2. Government General Hospital, Chennai
3. Government Rajaji Hospital, Madurai
Study Duration: 36 months
Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing
the incidence of tuberculosis and mortality among HIV-infected persons
Study Design:
The study will be a two-armed prospective randomized clinical trial among HIV- positive
patients without active tuberculosis. Enrolled patients will be assigned to one of the two
unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3
years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be
compared in each group.
Study Endpoints:The primary end point of the study will be development of tuberculosis and
the secondary endpoints will include adverse drug reactions and mortality rate.
Phase:
Phase 3
Details
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborator:
United States Agency for International Development (USAID)