Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Tuberculosis Research Centre, India |
---|---|
Information provided by: | Tuberculosis Research Centre, India |
ClinicalTrials.gov Identifier: | NCT00376012 |
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
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).
Condition | Intervention | Phase |
---|---|---|
Tuberculosis Human Immunodeficiency Virus Infections |
Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial to Assess the Efficacy of Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis |
Enrollment: | 300 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
2EHRZ3/4RH3
|
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.
|
2: Experimental
2EHRZ3/7RH3
|
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.
|
Ages Eligible for Study: | 15 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Tamilnadu | |
Tuberculosis Research Centre | |
Chennai, Tamilnadu, India, 600 031 |
Principal Investigator: | Soumya Swaminathan, MD MNAMS | Tuberculosis Research Centre, India |
Responsible Party: | Tuberculosis Research centre ( Soumya Swaminathan ) |
Study ID Numbers: | trc20A |
Study First Received: | September 13, 2006 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00376012 |
Health Authority: | India: Indian Council of Medical Research |
Chemotherapy for TB in HIV infection |
Bacterial Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Pyrazinamide Immunologic Deficiency Syndromes Virus Diseases Rifampin Gram-Positive Bacterial Infections |
HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Ethambutol Retroviridae Infections Isoniazid |
Antimetabolites Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Antilipemic Agents Enzyme Inhibitors Infection Actinomycetales Infections |
Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Nucleic Acid Synthesis Inhibitors Fatty Acid Synthesis Inhibitors Leprostatic Agents |