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Pulmonary Tuberculosis (TB)Phase 2NCT07303699

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

A Phase 2 study testing Atorvastatin 20 mg, Atorvastatin 40 mg and Atorvastatin 60 mg in people with Pulmonary Tuberculosis (TB), run by Obafemi Awolowo University Teaching Hospital at 3 sites in Nigeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pulmonary Tuberculosis (TB)
What is being tested?
Atorvastatin 20 mg, Atorvastatin 40 mg and Atorvastatin 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesNigeria
Study dates
3 Jan 2026to 30 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olanisun O Adewole, MD contact

+2348034074930

adewolef@yahoo.co.uk , ola.adewole@oauife.edu.ng

Nigeria3 sites, 3 recruiting

  • Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria

    Ile-Ife, Osun State, 2345

    Olanisun O Adewole, MD, +2348034074930, adewolef@yahoo.co.uk , ola.adewole@oauife.edu.ng

    Bolanle A Omotoso, MD, +2347037350229, bolamotee@yahoo.co.uk

    Recruiting

  • Federal Teaching Hospital

    Katsina, Katsina State

    Taofeek Oloyede, MD, +2348029423132

    Taofeek Oloyede, MD

    Recruiting

  • National Tuberculosis and Leprosy Training Centre, Saye

    Zaria, Kaduna State

    Eunice N Jiya - Chitumu, MD, +2348033714310

    Eunice Jiya, MD

    Recruiting

Other trials in Nigeria

About this study

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)

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 the detailed description

This is a pharmacokinetics-pharmacodynamics sub-study of ATORTUB trial (NCT06199921) and a dose finding study of atorvastatin in adults with pulmonary TB.

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 sparse pharmacokinetic sampling will be done at each visit.

The pharmacokinetic/ Pharmacodynamic data for atorvastatin will be used to identify a dose to be studied as adjunctive TB treatment in subsequent trials.

Being tested
Atorvastatin 20 mg, Atorvastatin 40 mg, Atorvastatin 60 mg, Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
Keywords
Pulmonary TB, Pulmonary Tuberculosis, Tuberculosis, Koch's disease, Mycobacterium tuberculosis, Isoniazid, Atorvastatin, Rifampicin, Rifampin, Ethambutol, pyrazinamide, Intensive Phase, Continuation Phase, statins, Antitubercular therapy (ATT)
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 20 mgDrug

    Also called Astin

    Participants will receive 16weeks of daily oral treatment with 20mg atorvastatin 4AT(20)]

  • Atorvastatin 40 mgDrug

    Also called Astin

    Participants will receive 16 weeks of daily oral treatment with 40mg atorvastatin 4AT(40)]

  • Atorvastatin 60 mgDrug

    Also called Astin

    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)Drug

    Also called Stop TB Kit

    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]

Study groups in NCT07303699
Study groupRoleWhat they receive
20mg atorvastatin with standard of care (SOC) for TBExperimentalTrial of 20mg atorvastatin with standard of care (SOC) for TB [2RHZE/4RH + 4AT(20)]
Receives: Drug: Atorvastatin 20 mg; Drug: Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
40mg atorvastatin with standard of care (SOC) for TBExperimentalTrial of 40mg atorvastatin with standard of care (SOC) for TB [2RHZE/4RH + 4AT(40)]
Receives: Drug: Atorvastatin 40 mg; Drug: Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
60mg atorvastatin with standard of care (SOC) for TBExperimentalTrial of 60mg atorvastatin with standard of care (SOC) for TB [2RHZE/4RH + 4AT(60)]
Receives: Drug: Atorvastatin 60 mg; Drug: Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)
standard of care (SOC) for TBActive comparatorStandard of Care (SOC) for TB [2RHZE/4RH]
Receives: Drug: Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration versus time curve (AUC 0-24) for atorvastatin acid, rifampicin, isoniazid and their metabolites at steady state

    Sparse pharmacokinetic sampling will be employed during participants treatment follow up visits for the determination of plasma concentrations of atorvastatin acid, rifampicin, isoniazid. and their active metabolites (2-hydroxyl atorvastatin 4- hydroxyl atorvastatin, acetyl - isoniazid, desacetyl - rifampicin). AUC will be estimated using Population Pharmacokinetics analysis

    Measured: Sampling will be on day 14 & week 8, 16 and 24 post randomization

  2. Peak Plasma Concentration (Cmax) for atorvastatin acid, rifampicin, isoniazid and their metabolites at steady state

    Sparse pharmacokinetic sampling will be employed during participants treatment follow up visits for the determination of plasma concentrations of atorvastatin acid, rifampicin, isoniazid. and their active metabolites (2-hydroxyl atorvastatin 4- hydroxyl atorvastatin, acetyl - isoniazid, desacetyl - rifampicin). Cmax will be estimated using Population Pharmacokinetics analysis

    Measured: Sampling will be on day 14 & week 8, 16 and 24 post randomization

  3. Plasma Clearance (Cl/F) in mL/min of atorvastatin acid, rifampicin, isoniazid and their metabolites at steady state

    Sparse pharmacokinetic sampling will be employed during participants treatment follow up visits for the determination of plasma concentrations of atorvastatin acid, rifampicin, isoniazid. and their active metabolites (2-hydroxyl atorvastatin 4- hydroxyl atorvastatin, acetyl - isoniazid, desacetyl - rifampicin). Plasma clearance of aforementioned drugs and metabolites will be estimated using Population Pharmacokinetics analysis

    Measured: Sampling will be on day 14 & week 8, 16 and 24 post randomization

Secondary outcomes (9)

  1. Correlation between AUC 0-24 of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin at steady state and days 0-14 early bactericidal activity in participants on atorvastatin-based regimens

    steady state AUC 0-24 of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin will be correlated with early bactericidal activity on day 14. Early bactericidal activity will be measured as the daily rate of change in log10 Colony Forming Units of M. Tuberculosis in Sputum on Solid Media

    Measured: day 14 post randomization

  2. Correlation between Cmax of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin at steady state and days 0-14 early bactericidal activity in participants on atorvastatin-based regimens

    Cmax of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin will be correlated with early bactericidal activity on day 14. Early bactericidal activity will be measured as the daily rate of change in log10 Colony Forming Units of M. Tuberculosis in Sputum on Solid Media

    Measured: day 14 post randomization

  3. Correlation between Cmax of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin at steady state and time to stable sputum culture conversion

    Time to achieve culture negative sputum result as measured by growth on solid mycobacteria culture medium

    Measured: 2 - 24 weeks post randomization

  4. Correlation between AUC 0-24 of atorvastatin, atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin) at steady state and change in baseline chest Xray severity score at 4, 6 and 12 months

    Change in baseline chest Xray severity score as measured by Timika Chest X ray scoring system. At least 30% reduction in Chest x-ray severity score is desirable

    Measured: 16 -52weeks post randomisation

  5. Correlation between AUC 0-24 of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin at steady state and time to stable sputum culture conversion

    Time to achieve culture negative sputum result as measured by growth on solid mycobacteria culture medium

    Measured: 2 - 24 weeks post randomization

  6. Correlation between Cmax of atorvastatin, atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin) at steady state and change in baseline chest Xray severity score at 4, 6 and 12 months

    Change in baseline chest Xray severity score as measured by Timika Chest X ray scoring system. At least 30% reduction in Chest x-ray severity score is desirable

    Measured: 16 - 52 weeks post randomization

  7. Correlation between AUC 0-24 of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin) at steady state and change in baseline lung function at 4, 6 and 12 months

    Change in baseline lung function (FEV1 and FVC) test will be assessed using a spirometer at 4, 6 and 12 months. At least 15% improvement in FEV1 and FVC is desirable.

    Measured: 16 -52 weeks post randomization

  8. Correlation between Cmax of atorvastatin acid, 2-hydroxyl atorvastatin and 4- hydroxyl atorvastatin) at steady state and change in baseline lung function at 4, 6 and 12 months

    Change in baseline lung function (FEV1 and FVC) test will be assessed using a spirometer at 4, 6 and 12 months. At least 15% improvement in FEV1 and FVC is desirable.

    Measured: 16 - 52 weeks post randomization

  9. The optimal dose of atorvastatin that will be safe and effective as an adjunctive pulmonary TB treatment

    A pharmackinetic - Pharmacodynamic (PK/ PD) model will be developed for each drug (using PK -PD data generated from other secodary outcomes described above) and the the optimal dose of atorvastatin that will be appropriate as adjunctive TB treatment will be investigated using Monte-Carlo simulations.

    Measured: week 52 post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start3 Jan 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303699
Sponsor's protocol ID
ERC/2023/11/15/B
Other IDs
IRB/IEC/0004553
Status last verified
Jan 2026
First submitted
21 Sep 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin 20 mg, Atorvastatin 40 mg and Atorvastatin 60 mg in people with Pulmonary Tuberculosis (TB), run by Obafemi Awolowo University Teaching Hospital at 3 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olanisun O Adewole, MD (+2348034074930, adewolef@yahoo.co.uk , ola.adewole@oauife.edu.ng), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the plasma concentration versus time curve (AUC 0-24) for atorvastatin acid, rifampicin, isoniazid and their metabolites at steady state (time frame: Sampling will be on day 14 & week 8, 16 and 24 post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07303699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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