Status:
COMPLETED
Preventive Therapy for Tuberculosis in HIV Infected Persons
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
United States Agency for International Development (USAID)
Conditions:
Human Immunodeficiency Virus
Tuberculosis
Eligibility:
All Genders
15-60 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Study population and enrollment: All HIV positive patients seeking care at one of the study centers, above the age of 15 years, not suffering from a serious illness, non-pregnant, and in whom TB was ...
Eligibility Criteria
Inclusion
- Age \> 15 years
- HIV positivity (on 2 different ELISA tests on the same blood sample)
- Living in Chennai or Madurai within a defined area of intake - 25 km radius.
- Likely to remain in the same area for at least three years after start of treatment
- The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
- Is agreeable for home visits
- No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
- No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
- 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
- Resides outside area of intake.
- Pregnancy and lactation.
- Patients with major psychiatric illnesses and severe depression
- Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
- Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
- Previous antituberculosis treatment for more than 1 month
- Patients on ART -
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT00351702
Start Date
February 1 2001
End Date
June 1 2011
Last Update
May 22 2024
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, Tamil Nadu, India, 600 031