Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
- Conditions
- Tuberculosis, Pulmonary
- Registration Number
- NCT04147286
- Lead Sponsor
- University of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria<br><br> 1. Has completed the written informed consent process prior to undergoing any<br> pre-screening or screening evaluations and willing to undergo HIV testing<br><br> 2. Age 18 to 65 years with body weight from 50 kg to 90 kg<br><br> 3. Clinical response to TB treatment and sputum culture negative at week 16<br><br> 4. Completed a 24-week course of standard TB treatment (4RHZE/2RH)<br><br> 5. Defined as cured by the TB Control Program of South Africa<br><br> Laboratory parameters within 30 days before enrolment:<br><br> 6. For HIV-infected participants: receiving antiretroviral therapy for at least 12<br> weeks and suppressed HIV viral load within 30 days prior to enrolment<br><br> 7. For HIV-infected participants: CD4 counts above 350 cells/µL within 30 days prior to<br> enrolment<br><br> 8. AST and ALT <3x upper limit of normal (ULN)<br><br> 9. Creatinine <2x ULN<br><br> 10. Hemoglobin >7.0 g/dL<br><br> 11. Platelet count >50 x109 cells/L<br><br> 12. Creatinine kinase <2x ULN<br><br> 13. Able and willing to return to follow-up<br><br> 14. Willing to have samples, including DNA, stored<br><br> 15. Willing to consistently practice a highly reliable method of pregnancy prevention<br><br>Exclusion criteria<br><br> 1. Acute illness<br><br> 2. Fever (temperature >38.0 degrees centigrade)<br><br> 3. Participant receiving any type of lipid lowering agent at the time of screening,<br> within three months prior to screening or likely to require any lipid lowering agent<br> in the near future.<br><br> 4. Known allergy or contraindications to the investigational drug or any other statins<br><br> 5. Evidence of drug-resistant TB<br><br> 6. Extrapulmonary TB, including pleural TB and/or large pleural effusion<br><br> 7. Pregnant or desiring/trying to become pregnant in the next 6 months<br><br> 8. Unable to take oral medications<br><br> 9. Diabetes as defined by point of care HbA1c=6.5, random glucose=200mg/dL (or<br> 11.1mmol/L), fasting plasma glucose=126mg/dL (or 7.0mmol/L), or the presence of any<br> anti-diabetic agent (including traditional medicines) as a concomitant medicine<br><br> 10. Disease complications or concomitant illnesses that may compromise safety or<br> interpretation of trial endpoints, such as known diagnosis of chronic inflammatory<br> condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)<br><br> 11. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or<br> inhaled corticosteroids, within the past 2 weeks<br><br> 12. Use of any investigational drug in the previous 3 months<br><br> 13. Alcohol and substance abuse which might interfere with medication adherence during<br> the trial<br><br> 14. Any person for whom the physician feels this study is not appropriate
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total lung glycolysis (TLG) on PET/CT imaging
- Secondary Outcome Measures
Name Time Method