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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tuberculosis Research Centre, India.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tuberculosis Research Centre, India
ClinicalTrials.gov Identifier:
NCT00376012
First received: September 13, 2006
Last updated: June 10, 2008
Last verified: May 2008
  Purpose

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).


Condition Intervention Phase
Tuberculosis
Human Immunodeficiency Virus Infections
Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Assess the Efficacy of Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis

Resource links provided by NLM:


Further study details as provided by Tuberculosis Research Centre, India:

Primary Outcome Measures:
  • Primary outcome measures are TB cure and relapse rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome measure is mortality rates. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Active Comparator: 1
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.
Experimental: 2
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 15 years
  2. HIV positivity (on 2 different ELISA tests on the same blood sample)
  3. Living in Chennai or Madurai within a defined area of intake - 25 km radius.
  4. Likely to remain in the same area for at least three years after start of treatment
  5. The patient is judged to be cooperative and willing for thrice-weekly attendance for the first 2/3 months and once-weekly thereafter for the next 4 to 7 months
  6. Is agreeable for home visits
  7. No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
  8. No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
  9. Patients who fulfill laboratory criteria (hemoglobin =>70 g/L, granulocyte count >1.1 X 109/L, platelet count > 100X 109/L, serum alanine amino transferase concentration <2.5 times the upper limit of normal, serum creatinine concentration <1.1mg%, random blood sugar < 140 mg/dl) will be enrolled in to the study

Exclusion Criteria:

  1. Resides outside area of intake.
  2. Pregnancy and lactation.
  3. Patients with major psychiatric illnesses and severe depression
  4. Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
  5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
  6. Previous antituberculosis treatment for more than 1 month.
  7. Patients on ART
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376012

Locations
India
Tuberculosis Research Centre
Chennai, Tamilnadu, India, 600 031
Sponsors and Collaborators
Tuberculosis Research Centre, India
Investigators
Principal Investigator: Soumya Swaminathan, MD MNAMS Tuberculosis Research Centre, India
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soumya Swaminathan, Tuberculosis Research centre
ClinicalTrials.gov Identifier: NCT00376012     History of Changes
Other Study ID Numbers: trc20A
Study First Received: September 13, 2006
Last Updated: June 10, 2008
Health Authority: India: Indian Council of Medical Research

Keywords provided by Tuberculosis Research Centre, India:
Chemotherapy for TB in HIV infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ethambutol
Isoniazid
Pyrazinamide
Rifampin
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 22, 2014