Status:
COMPLETED
Anti-tuberculosis (TB) Drug Levels and Hepatotoxicity
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Hepatitis
Tuberculosis
Eligibility:
All Genders
16-65 years
Brief Summary
The purpose of this study is to evaluate plasma levels of hepatotoxic anti-tuberculous drugs (isoniazid, rifampicin, pyrazinamide plus significant metabolites) among patients on antituberculosis treat...
Detailed Description
Tuberculosis (TB) is a major health problem in both the developing and developed countries because of its resurgence in the immunosuppressed patients. World Health Organization (WHO) in 1993 declared ...
Eligibility Criteria
Inclusion
- Patients diagnosed to be suffering from CatI/CatIII tuberculosis by a physician
- Age: 16-65 years
- Patient having normal baseline Liver function (AST/ALT1 \< 50/50, serum bilirubin \< 1.5 mg/dl)
Exclusion
- Patients receiving any other drug known to be metabolized by liver by cytochrome P450 3A4 or P-glycoprotein
- Patients diagnosed to have acute viral hepatitis A, B, C, or E or carrier for HBV \& HCV
- Known HIV positive patients
- Presence of chronic liver disease or renal insufficiency
- Concomitant administration of other potential hepatotoxic drugs (methotrexate, phenytoin, valproate)
- Chronic alcoholics who consume \> 48 g of alcohol/day for at least one year
- Pregnant women
- Subjects not willing to participate
- Known patients with malabsorption or drug abuse
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00929786
Start Date
November 1 2007
End Date
June 1 2009
Last Update
November 10 2009
Active Locations (2)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
2
All India Institute of Medical Sciences
New Delhi, New Delhi, India, 110029