ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)

Exclusion Criteria

• •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.
• •Known or family history of bleeding disorders.
• •Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.
• •Myositis and or Creatinine phosphokinase three times upper limit of normal
• •Patient in a moribund state
• •Has TB meningitis
• •Presence of any of the pre-existing non-TB diseases outlined in the protocol
• •Diabetes mellitus
• •Hypertension
• •Currently on anti TB medication
• •Any other chronic illness/ co morbidities that warrants being on daily routine medications
• •Presence of a psychiatric illness
• •pregnant, or breast feeding mothers
• •Current Tobacco Smokers/ tobacco use in any form
• •Alcoholism
• •alcoholic beverages, food or drinks containing methyl- xanthine (i.e. energy drinks, tea leaves, coffee beans, cocoa, kola nuts, medications e.g. theophylline). Ingestion of grapefruit/ products containing grapefruit juice, bitter oranges, garlic supplements, St John's Wort or other herbal supplements, within 7 days prior to the first treatment and throughout the study will not be allowed.
• •Individuals that are enrolled in other therapeutic clinical trials