NCT07303699 ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2026-01-03 with a primary completion date of 2027-03-30.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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 * Agreement to participate in the study and to give a sample of blood for HIV testing * Normal baseline laboratory values at or within 14 days prior to screening: * Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal * Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal * Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal * Serum or plasma potassium level greater than or equal to 3.5 meq/L * Hemoglobin level of 7.0 g/dL or greater * Platelet count of 100,000/mm3 or greater * Informed consent to participate in the study and to give a sample of blood for HIV testing 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

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