ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Population Pharmacokinetics and Pharmacodynamics of Standard First Line Anti-TB Versus Atorvastatin-Containing Regimens in the Treatment of Pulmonary Tuberculosis: A Sub-study of the ATORTUB Phase 2C Randomized Controlled Trial (ATORTUB popPK-PD Study)
About This Trial
The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK/PD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Atorvastatin 20 mg
Participants will receive 16weeks of daily oral treatment with 20mg atorvastatin 4AT(20)\]
Atorvastatin 40 mg
Participants will receive 16 weeks of daily oral treatment with 40mg atorvastatin 4AT(40)\]
Atorvastatin 60 mg
Participants will receive 16weeks of daily oral treatment with 60mg atorvastatin 4AT(60)
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]