Actively Recruiting
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Led by University of Cape Town · Updated on 2024-08-23
220
Participants Needed
1
Research Sites
376 weeks
Total Duration
On this page
Sponsors
U
University of Cape Town
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years with body weight from 50 kg to 90 kg
- Completed a 24-week course of standard TB treatment (4RHZE/2RH)
- Clinical response to TB treatment and sputum culture negative at week 16
- Defined as "cured" by the TB Control Program of South Africa
- For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment
- For HIV-infected participants: CD4 counts above 350 cells/bcL within 30 days prior to enrolment
- AST and ALT less than 3 times the upper limit of normal
- Creatinine less than 2 times the upper limit of normal
- Hemoglobin greater than 7.0 g/dL
- Platelet count greater than 50 x10^9 cells/L
- Creatinine kinase less than 2 times the upper limit of normal
- Able and willing to return for follow-up visits
- Willing to have samples, including DNA, stored
- Willing to consistently practice a highly reliable method of pregnancy prevention
You will not qualify if you...
- Acute illness
- Fever over 38.0 degrees centigrade
- Currently receiving or recently received any lipid lowering agent within 3 months
- Known allergy or contraindication to atorvastatin or any statins
- Evidence of drug-resistant tuberculosis
- Extrapulmonary tuberculosis, including pleural TB or large pleural effusion
- Pregnant or planning to become pregnant in the next 6 months
- Unable to take oral medications
- Diabetes as defined by elevated blood sugar or use of any anti-diabetic agents
- Chronic inflammatory conditions such as sarcoidosis, rheumatoid arthritis, or connective tissue disorders
- Use of immunosuppressive medications like TNF-alpha inhibitors or corticosteroids within the past 2 weeks
- Use of any investigational drug in the previous 3 months
- Alcohol or substance abuse that might interfere with medication adherence
- Any condition the physician feels makes the study inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
General Medicine & Global Health, Cape Heart Institute, Faculty of Health Sciences, University of Cape Town
Observatory, WC, South Africa, 7925
Actively Recruiting
Research Team
F
Friedrich Thienemann, MD
CONTACT
S
Sandra Mukasa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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