Status:
UNKNOWN
Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
Lead Sponsor:
Tuberculosis Research Centre, India
Conditions:
Tuberculosis
Human Immunodeficiency Virus Infections
Eligibility:
All Genders
15-60 years
Phase:
PHASE3
Brief 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 pat...
Detailed Description
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 diagnosed with TB will be briefly explained the tr...
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 thrice-weekly attendance for the first 2/3 months and once-weekly thereafter for the next 4 to 7 months
- 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 =\>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
- 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 :
September 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00376012
Start Date
February 1 2001
End Date
September 1 2008
Last Update
June 11 2008
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, Tamil Nadu, India, 600 031