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Preventive Therapy for Tuberculosis in HIV Infected Persons

NCT00351702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 683

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Isoniazid with Ethambutol

Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Tuberculosis Research Centre, India

    lead OTHER_GOV

Principal Investigators

  • Soumya Swaminathan, MD MNAMS · Tuberculosis Research Centre, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2008-09-30
Completion
2011-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00351702 on ClinicalTrials.gov