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

NCT00376012 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2008-06-11

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)

Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months.

DRUG

Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)

Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 7 months.

Sponsors & Collaborators

  • Tuberculosis Research Centre, India

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
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
2007-09-30
Completion
2008-09-30

Countries

  • India

Study Locations

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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 NCT00376012 on ClinicalTrials.gov