Clinical Research Directory
Browse clinical research sites, groups, and studies.
ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Sponsor: Obafemi Awolowo University Teaching Hospital
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-01-03
Completion Date
2028-03-30
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
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 \[2RHZE/4RH\]
Locations (3)
National Tuberculosis and Leprosy Training Centre, Saye
Zaria, Kaduna State, Nigeria
Federal Teaching Hospital
Katsina, Katsina State, Nigeria
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria
Ile-Ife, Osun State, Nigeria