Using Atorvastatin to treat Pulmonary Tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Atorvastatin, a cholesterol-lowering medication, as an adjunct treatment for patients with pulmonary tuberculosis. The study aims to evaluate the efficacy of different doses of Atorvastatin (20mg, 40mg, and 60mg) in improving treatment outcomes for individuals diagnosed with TB. Participants must be treatment-naive and meet specific inclusion criteria, including age and HIV status. The trial will be conducted at multiple locations in Nigeria, focusing on areas with a high burden of tuberculosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Tuberculosis Reference Laboratory
  Zaria, Kaduna State, Nigeria Recruiting
• Federal Teaching Hospital
  Katsina, Katsina State, Nigeria Recruiting
• Federal Medical Center
  Keffi, Nasarawa State, Nigeria Recruiting
• Obafemi Awolowo University Teaching Hospitals Complex
  Ile-Ife, Osun State, Nigeria Recruiting
• Bowen University Teaching Hospital
  Iwo, Osun State, Nigeria Recruiting
• University College Hospital
  Ibadan, Oyo State, Nigeria Recruiting

Study contacts

• Principal investigator: Olanisun O Adewole, MD — Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, 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

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.