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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuberculosis Research Centre, India
• Treatments: Ethambutol; Isoniazid; Pyrazinamide; Rifampin

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