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.
Eligibility criteria
Qualifiers
Sputum specimen positive for tubercle bacilli on Gene Xpert or direct smear microscopy
Either no previous anti-TB chemotherapy, or less than 2 weeks of previous chemotherapy
Aged 12years and above
A firm home address that is readily accessible for visiting
Disqualifiers
Participants known or suspected of having any form of drug resistance TB.
Patients co infected with HIV
Those with poor general condition where no delay in treatment can be tolerated
Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.
Trial design
Treatments tested in this trial
- Atorvastatin 20 mg
- Atorvastatin 40 mg
- Atorvastatin 60 mg
- Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Treatment groups
Sponsors and collaborators
Obafemi Awolowo University Teaching Hospital
Lead sponsor
Open Philanthropy
Collaborator
Obafemi Awolowo University
Collaborator