StatinTB Trial

Phase 2

Recruiting

• Conditions: Tuberculosis; Respiratory

• Registration Number: PACTR202211865409139
• Lead Sponsor: niversity of Cape Town

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

1. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing
2. Age 18 to 65 years with body weight from 50 kg to 90 kg
3. Clinical response to TB treatment and sputum culture negative at week 16
4. Completed a course of standard TB treatment
Laboratory parameters within 30 days before enrolment:
5. For HIV-infected participants: suppressed HIV viral load within 30 days prior to enrolment
6. AST and ALT <3x upper limit of normal (ULN)
7. Creatinine <2x ULN
8. Hemoglobin >7.0 g/dL
9. Platelet count >50 x109 cells/L
10. Creatinine kinase <2x ULN
11. Able and willing to return to follow-up
12. Willing to have samples, including DNA, stored
13. Willing to consistently practice a highly reliable method of pregnancy prevention

Exclusion Criteria

1. Acute illness
2. Fever (temperature >38.0 degrees centigrade)
3. Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any lipid lowering agent in the near future.
4. Known allergy or contraindications to the investigational drug or any other statins
5. Any drug with significant drug-drug interaction that increase exposure to atorvastatin and potentially the risk for the participants (E.g. protease inhibitors)
6. Evidence of drug-resistant TB
7. Extrapulmonary TB, including pleural TB and/or large pleural effusion
8. Pregnant or desiring/trying to become pregnant in the next 6 months
9. Unable to take oral medications
10. Diabetes as defined by HbA1c=6.5, random glucose=200mg/dL (or 11.1mmol/L), fasting plasma glucose=126mg/dL (or 7.0mmol/L), or the presence of any anti-diabetic agent as a concomitant medicine
11. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
12. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
13. Use of any investigational drug in the previous 3 months
14. Alcohol and substance abuse which might interfere with medication adherence during the trial
15. Any person for whom the physician feels this study is not appropriate
16. Positive SARS-CoV-2 PCR or SARS-CoV-2 Rapid Antigen Test in the past 4 weeks
17. Claustrophobia - only for patients opting to undergo cardiac MRI
18. Pacemaker, bullet injury or ferromagnetic device or surgical clip (e.g. brain aneurysm clip, aortic clip, heart valve, insulin pump, IUD, joint replacement, protheses, wire sutures, dentures) - only for patients opting to undergo cardiac MRI
19. Allergy to CMR contrast media - only for patients opting to undergo cardiac MR

Study & Design

• Study Type: Interventional
• Study Design: Not specified