Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Recruiting
Phase 2Phase 3Interventional Study
Tuberculosis, Pulmonary
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
University of Cape Town · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in HIV-infected and HIV-uninfected adults measured by PET/CT.
Trial Locations
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Status
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 w…
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
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