Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion

Launched by UNIVERSITY OF CAPE TOWN · Oct 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called atorvastatin can help reduce lung inflammation in adults who have successfully completed treatment for tuberculosis (TB). Researchers want to find out if taking atorvastatin can improve recovery after TB, especially for patients with and without HIV. Participants will be randomly assigned to receive either atorvastatin or a placebo (a pill that looks the same but has no active medication) to see how well it works. The study is currently looking for participants aged 18 to 65 who have completed their TB treatment and are considered cured.

To be eligible, participants must have a recent negative TB test and be in good overall health, meaning they don’t have other serious illnesses or conditions that could interfere with the study. Participants will need to attend follow-up appointments and agree to some health tests, including an HIV test. Throughout the trial, they can expect regular check-ins and monitoring to ensure their safety and track how well the treatment is working. It’s important for participants to understand that this study is primarily focused on safety and how effective atorvastatin is in reducing inflammation after TB treatment.

Gender

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Eligibility criteria

• • 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 24-week course of standard TB treatment (4RHZE/2RH)
• • 5. Defined as "cured" by the TB Control Program of South Africa
• Laboratory parameters within 30 days before enrolment:
• • 6. For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment
• • 7. For HIV-infected participants: CD4 counts above 350 cells/µL within 30 days prior to enrolment
• • 8. AST and ALT \<3x upper limit of normal (ULN)
• • 9. Creatinine \<2x ULN
• • 10. Hemoglobin \>7.0 g/dL
• • 11. Platelet count \>50 x109 cells/L
• • 12. Creatinine kinase \<2x ULN
• • 13. Able and willing to return to follow-up
• • 14. Willing to have samples, including DNA, stored
• • 15. 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. Evidence of drug-resistant TB
• • 6. Extrapulmonary TB, including pleural TB and/or large pleural effusion
• • 7. Pregnant or desiring/trying to become pregnant in the next 6 months
• • 8. Unable to take oral medications
• • 9. Diabetes as defined by point of care 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 (including traditional medicines) as a concomitant medicine
• • 10. 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)
• • 11. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
• • 12. Use of any investigational drug in the previous 3 months
• • 13. Alcohol and substance abuse which might interfere with medication adherence during the trial
• • 14. Any person for whom the physician feels this study is not appropriate