Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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)

ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD) (NCT07303699) is a Phase 2 interventional studying Pulmonary Tuberculosis (TB), sponsored by Obafemi Awolowo University Teaching Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pulmonary Tuberculosis (TB) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pulmonary Tuberculosis (TB) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - willing to sign a consent form to participate in the study and to give a sample of blood for HIV testing Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Atorvastatin 20 mg

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

DRUG

Atorvastatin 40 mg

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

DRUG

Atorvastatin 60 mg

Participants will receive 16weeks of daily oral treatment with 60mg atorvastatin 4AT(60)

DRUG

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 \[2RHZE/4RH\]

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Tuberculosis and Leprosy Training Centre, Saye

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07303699), the sponsor (Obafemi Awolowo University Teaching Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07303699 clinical trial studying?

Who can participate in NCT07303699?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07303699?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07303699. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07303699. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.