ATORvastatin in Pulmonary TUBerculosis: a PharmacoKinetics Sub-study
NCT ID: NCT07303699
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2026-01-03
2027-09-30
Brief Summary
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Detailed Description
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It is a parallel dose comparison trial in which participants will be randomised into four treatment arms. Participants in the experimental arms of the study will receive standard anti-TB therapy for 24 weeks plus oral atorvastatin daily in the first 16 weeks. Study participants will be followed up for another 6 months post treatment. Total study duration for participants will be 52 weeks post randomization, during which participants will attend several study visits. Sputum specimen collection, chest Xray, lung function test, and pharmacokinetic assessments will be done at each visit.
The pharmacokinetic data for atorvastatin will be used to choose a dose to be studied as adjunctive TB treatment in subsequent trials.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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20mg atorvastatin with standard of care (SOC) for TB
Trial of 20mg atorvastatin with standard of care (SOC) for TB \[2RHZE/4RH + 4AT(20)\]
Atorvastatin 20 mg
Participants will receive 16weeks of daily oral treatment with 20mg atorvastatin 4AT(20)\]
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]
40mg atorvastatin with standard of care (SOC) for TB
Trial of 40mg atorvastatin with standard of care (SOC) for TB \[2RHZE/4RH + 4AT(40)\]
Atorvastatin 40 mg
Participants will receive 16 weeks of daily oral treatment with 40mg atorvastatin 4AT(40)\]
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]
60mg atorvastatin with standard of care (SOC) for TB
Trial of 60mg atorvastatin with standard of care (SOC) for TB \[2RHZE/4RH + 4AT(60)\]
Atorvastatin 60 mg
Participants will receive 16weeks of daily oral treatment with 60mg atorvastatin 4AT(60)
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]
standard of care (SOC) for TB
Standard of Care (SOC) for TB \[2RHZE/4RH\]
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]
Interventions
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Atorvastatin 20 mg
Participants will receive 16weeks of daily oral treatment with 20mg atorvastatin 4AT(20)\]
Atorvastatin 40 mg
Participants will receive 16 weeks of daily oral treatment with 40mg atorvastatin 4AT(40)\]
Atorvastatin 60 mg
Participants will receive 16weeks of daily oral treatment with 60mg atorvastatin 4AT(60)
Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Open Philanthropy
OTHER
Obafemi Awolowo University
OTHER
Obafemi Awolowo University Teaching Hospital
OTHER
Responsible Party
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Adewole Olufemi
Professor
Principal Investigators
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Olanisun O Adewole, MD
Role: PRINCIPAL_INVESTIGATOR
Obafemi Awolowo University / Teaching Hospital, Ile Ife, Nigeria
Bolanle A Omotoso, MD
Role: STUDY_DIRECTOR
Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria
Olanisun O Adewole, MD
Role: STUDY_CHAIR
Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria
Locations
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National Tuberculosis Reference Laboratory
Zaria, Kaduna State, Nigeria
Federal Teaching Hospital
Katsina, Katsina State, Nigeria
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria
Ile-Ife, Osun State, Nigeria
Countries
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Central Contacts
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Olanisun O Adewole, MD
Role: CONTACT
Phone: +2348034074930
Email: [email protected] , [email protected]
Facility Contacts
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Eunice Jiya, MD
Role: primary
Olanisun O Adewole, MD
Role: primary
Bolanle A Omotoso, MD
Role: backup
Other Identifiers
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IRB/IEC/0004553
Identifier Type: OTHER
Identifier Source: secondary_id
ERC/2023/11/15/B
Identifier Type: -
Identifier Source: org_study_id