SNPMiner Trials (Home Page)
Report for SNP rs4149032
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Personalization of AntiTB Treatment: Evaluation of Pharmacological Determinants of Treatment Response
The aim of the study is to investigate the possible correlation of plasma drug concentrations with Time To Positivity (TTP) in liquid culture in patients with active pulmonary multi sensitive TB in the first two weeks of treatment. Secondary aims are: the correlation between plasma drug concentrations and hepato/neuro toxicity; the impact of different allelic variants on PK data, toxicity and TTP in liquid culture; the feasibility of using dried blood/plasma spots to measure plasma concentrations of anti-TB drugs and determine genetic polymorphisms.
NCT03416309 Tuberculosis, Pulmonary MeSH:Tuberculosis Tuberculosis, Pulmonary
Analyzed SNPs will be: ABCB1 3435C>T (rs1045642), OATP1B1 521T>C (rs4149056) e OATP1B1 85-7793T>C (rs4149032), PXR 63396C>T (rs2472677), BsmI G>A (rs1544410).
Primary Outcomes
Description: Investigate the correlation of plasma drug concentrations (Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, HRZE) with the change in Time To Positivity (TTP) in liquid culture in patients with active pulmonary TB between the baseline and the first week of treatment.
Measure: Correlation between AUC of RHZE and TTP Time: 1 week from start of treatmentDescription: Investigate the correlation of plasma drug concentrations (Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, HRZE) with the change in Time To Positivity (TTP) in liquid culture in patients with active pulmonary TB between the baseline and the second week of treatment.
Measure: Correlation between AUC of RHZE and TTP Time: 2 weeks from start of treatmentSecondary Outcomes
Description: Investigate the correlation of plasma drug concentrations (Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, HRZE) with hepatotoxicity (increase of AST and/or ALT) and neurotoxicity (peripheral neuropathy)
Measure: Correlation between AUC of RHZE and toxicity Time: 1 week and 2 weeks from start of treatmentDescription: Investigate the impact of different allelic variants of NAT2, SLCO1B1, ABCB1, VDR on AUC of RHZE toxicity and TTP in liquid culture
Measure: Correlation between PG and AUC of RHZE Time: 1 week and 2 weeks from start of treatmentDescription: Assess the consistency of using dried plasma spots to measure plasma concentrations of anti-TB drugs comparing to plasma samples
Measure: Assess the consistency of results using of DPS for measuring the plasma drug concentrations Time: 1 week and 2 weeks from start of treatmentDescription: A pharmacometric model will be develop to correlate pharmacokinetics (AUC of RHZE) with the anti-TB treatment response (clinical and TTP) of the standard first-line anti-TB regimen.
Measure: Correlate AUC of RHZE with antiTB response Time: 6 months after end of treatmentDescription: A pharmacometric model will be develop to correlate PG with the anti-TB treatment response (clinical and TTP) of the standard first-line anti-TB regimen.
Measure: Correlate PG with antiTB response Time: 6 months after end of treatment