Genetic risk factors for hepatotoxicity during anti tuberculosis treatment.
- Conditions
- leverbijwerkingen van standaard tuberculosebehandelinghepatotoxicityliver side effects10028440
- Registration Number
- NL-OMON29714
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 325
Inclusion Criteria
- Patient is treated for tuberculosis (pulmonary or extra-pulmonary) with standard treatment containing at least isoniazid, rifampicin and pyrazinamide.
- Age: above 18 years.
Exclusion Criteria
- Patient receives treatment for multi-drug resistant tuberculosis.
- Patient also receives antiretroviral treatment and developed liver function disorders immediately after the start of ART.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Association between ATDH and genetic polymorphisms (single nucleotide<br /><br>polymorphisms) in drug metabolising enzymes and regulators of enzyme<br /><br>expression.<br /><br>Enzymes: N-acetyltransferase 2, glutathione S-transferase, cytochrome P450 2E1.<br /><br>Receptors: pregnane X-receptor (PXR), multidrug resistance gene 1 (MDR1).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Association between ATDH and other risk factors, including age, sex, weight and<br /><br>length, underlying liver disease and HIV-status. </p><br>