Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

ATORvastatin in Pulmonary TUBerculosis

Atorvastatin-containing Treatment Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled phase2C/3 Clinical Trial

ATORvastatin in Pulmonary TUBerculosis (NCT06199921) is a Phase 2 interventional studying Pulmonary Tuberculosis and Tuberculosis, 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

Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies. This phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pulmonary Tuberculosis 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.

A target enrollment of 440 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: Individuals must meet all the following inclusion criteria in order to participate in this study: A. Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with semiquantitative result of 'medium' or 'high' and rifampicin resistance not detected. B. Treatment naive C. Age twelve years or older D. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period. E. Documented HIV infection status. F. Documented blood sugar level/ Diabetes G. For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to screening. H. Laboratory parameters done 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 I. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening J. Written willing to sign a consent form Who Should NOT Join This Trial: Individuals with any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded. A. Pregnant or breast-feeding B. Unable to take oral medications C. Those already on treatment for tuberculosis D. Weight less than 40.0 kg E. Known allergy or intolerance to any of the study medications ...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: Individuals must meet all the following inclusion criteria in order to participate in this study: A. Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with semiquantitative result of 'medium' or 'high' and rifampicin resistance not detected. B. Treatment naive C. Age twelve years or older D. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period. E. Documented HIV infection status. F. Documented blood sugar level/ Diabetes G. For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to screening. H. Laboratory parameters done 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 I. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening J. Written informed consent Exclusion Criteria: Individuals with any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded. A. Pregnant or breast-feeding B. Unable to take oral medications C. Those already on treatment for tuberculosis D. Weight less than 40.0 kg E. Known allergy or intolerance to any of the study medications F. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide,or ethambutol, G. .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. H. Known or family history of bleeding disorders. I. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening. J. Myositis and or Creatinine phosphokinase three times upper limit of normal K. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest. Criteria for Exclusion after Enrollment ('Late Exclusion') Microbiological confirmation of drug-susceptible tuberculosis is not expected always to be available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria will be classified as 'late exclusions' and study treatment will be discontinued: A. Screening, baseline, and Week 2 study visit sputum cultures all fail to grow M. tuberculosis. B. M. tuberculosis cultured or detected through molecular assays (Cepheid Xpert MTB/RIF or Hain MTBDRplus assays) from sputum obtained around the time of study entry is determined to be resistant to one or more of isoniazid, rifampin, or fluoroquinolones.

Treatments Being Tested

DRUG

Atorvastatin 20mg

Participants will receive oral atorvastatin 20mg daily for 16 weeks

DRUG

Atorvastatin 40mg

Participants will receive oral atorvastatin 40mg daily for 16 weeks

DRUG

Atorvastatin 60mg

Participants will receive oral atorvastatin 60 mg daily for 16 weeks

DRUG

Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamide (Z) Ethambutol (E)

Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily oral treatment with rifampin, isoniazid

Locations (8)

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 Reference Laboratory

Zaria, Kaduna State, Nigeria

Federal Teaching Hospital

Katsina, Katsina State, Nigeria

Federal Medical Center

Keffi, Nasarawa State, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

Bowen University Teaching Hospital

Iwo, Osun State, Nigeria

University College Hospital

Ibadan, Oyo State, Nigeria

Usman Danfodio University

Sokoto, Sokoto State, Nigeria

University of Abuja Teaching Hospital

Gwagwalada, Nigeria

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06199921), 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 NCT06199921 clinical trial studying?

Who can participate in NCT06199921?

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 NCT06199921?

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 NCT06199921. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06199921. 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.