Preventive Therapy for Tuberculosis in HIV Infected Persons

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Tuberculosis Research Centre, India
• Collaborator: United States Agency for International Development (USAID)
• Treatments: Ethambutol; Isoniazid

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 fortnightly attendance for the next 3 years

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 > 7.0g/l,granulocyte count>11,000/l, platelet count > 1 lakh/l. serum alanine amino transferase concentration < 2.5 times the upper limit of normal and serum creatinine concentration < 1.1 mgs%, random blood sugar < 140 mgs%) will be enrolled into 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 -