Atorvastatin Added to Standard Treatment for Lung Tuberculosis: How the Body Handles It
Studies how the body processes atorvastatin alongside standard medicines in people with lung tuberculosis.
Plain-language title generated from the registry record
Registry title: ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Key facts
- Where
- Ile-Ife, Katsina, and Zaria, NigeriaSee the 3 sites
- Phase
- Phase 2
Where in Nigeria
- Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, NigeriaIle-Ife, NigeriaTaking people
- Federal Teaching HospitalKatsina, NigeriaTaking people
- National Tuberculosis and Leprosy Training Centre, SayeZaria, NigeriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Obafemi Awolowo University Teaching Hospital
- Trial code
- NCT07303699
- Record updated
- 23 January 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Participants known or suspected of having any form of drug resistance TB; Currently on anti TB medication; 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; 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; Presence of any of the pre-existing non-TB diseases outlined in the protocol; Diabetes mellitus; Hypertension; Any other chronic illness/ co morbidities that warrants being on daily routine medications; Presence of a psychiatric illness; 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; pregnant, or breast feeding mothers; Current Tobacco Smokers/ tobacco use in any form; Alcoholism; Individuals that are enrolled in other therapeutic clinical trials.