Atorvastatin with standard TB medication to find the best dose for pulmonary tuberculosis
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)
Run by Obafemi Awolowo University Teaching Hospital · NCT07303699 · Data updated 2026-11-12
This trial tests whether adding different daily doses of atorvastatin to standard treatment helps adults with drug-sensitive pulmonary tuberculosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Obafemi Awolowo University Teaching Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Zaria, Kaduna State and 2 other locations) |
| Status | Recruiting |
| Started | January 3, 2026 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT07303699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are people aged 12 and older with sputum-positive, drug-sensitive pulmonary TB who have had little or no prior anti-TB treatment, meet baseline lab criteria, agree to HIV testing, and can attend regular clinic visits at the study sites in Nigeria.
✕Probably not a fit
People with drug-resistant TB, significant baseline liver or kidney abnormalities, extensive prior anti-TB therapy, younger than 12 years, or who cannot commit to follow-up visits are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, parallel, dose-comparison pharmacokinetic–pharmacodynamic sub-study embedded in the ATORTUB program that enrolls adults with sputum-positive, drug-sensitive pulmonary TB. Participants are randomized into four arms (three different atorvastatin doses plus the standard fixed-dose anti-TB combination) and receive standard anti-TB therapy for 24 weeks while atorvastatin is given daily during the first 16 weeks in the experimental arms. The study collects sparse PK samples, PD measures, sputum specimens, chest x-rays, and lung function tests at scheduled visits and follows participants for a total of 52 weeks post-randomization. PK/PD modeling of atorvastatin concentrations and pharmacodynamic responses will be used to identify an optimal adjunctive dose for future TB trials.
Why it matters
Potential benefit: If successful, the study could identify an atorvastatin dose that improves treatment response when given alongside standard therapy for pulmonary TB.
How similar studies have gone: Preclinical research and small early-phase human studies have suggested statins may have beneficial host-directed effects in TB, but clinical evidence for atorvastatin as an adjunctive TB treatment remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
National Tuberculosis and Leprosy Training Centre, Saye
Zaria, Kaduna State, Nigeria Recruiting -
Federal Teaching Hospital
Katsina, Katsina State, Nigeria Recruiting -
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria
Ile-Ife, Osun State, Nigeria Recruiting
Study contacts
- Principal investigator: Olanisun O Adewole, MD — Obafemi Awolowo University / Teaching Hospital, Ile Ife, Nigeria
- Study coordinator: Olanisun O Adewole, MD
- Email: adewolef@yahoo.co.uk , ola.adewole@oauife.edu.ng
- Phone: +2348034074930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.