Actively Recruiting
Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion in HIV-infected and HIV-uninfected Adults Measured by FDG-PET/CT
Led by University of Cape Town · Updated on 2024-08-23
220
Participants Needed
1
Research Sites
104 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
Researchers are evaluating the safety and effectiveness of atorvastatin, a cholesterol-lowering drug, to reduce ongoing lung inflammation after successful tuberculosis (TB) treatment in adults with and without HIV. This trial is a phase IIB, double-blind, randomized, placebo-controlled study aiming to address persistent lung inflammation detected by PET/CT scans, which may contribute to TB relapse and long-term lung problems. The study builds on prior research suggesting statins may help reduce TB burden and lung damage by modulating immune responses and inflammation. Participants are randomly assigned to receive either 40 mg of atorvastatin or a matching placebo daily by mouth for 12 weeks following completion of standard TB treatment. The study compares lung inflammation between these two groups using PET/CT imaging to measure total lung glycolysis after the 12-week treatment period. The trial includes adults aged 18 to 65 who have completed successful TB therapy and have no drug-resistant TB or significant co-existing conditions that would interfere with participation. During the study, participants will undergo PET/CT scans to assess lung inflammation and provide various samples, including DNA, for research. Researchers will monitor lab tests such as liver and kidney function, blood counts, and HIV-related markers in infected participants. Participants must be willing to follow up regularly and practice effective pregnancy prevention. The main outcome is lung inflammation after treatment, and the total study period involves 12 weeks of treatment with follow-up assessments.
CONDITIONS
Brief Title
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has completed the written informed consent process and is willing to undergo HIV testing
- Age 18 to 65 years with body weight from 50 kg to 90 kg
- Clinical response to TB treatment and sputum culture negative at week 16
- Completed a 24-week course of standard TB treatment (4RHZE/2RH)
- Defined as "cured" by the TB Control Program of South Africa
- HIV-infected participants must have received antiretroviral therapy for at least 12 weeks and have suppressed HIV viral load within 30 days prior to enrolment
- HIV-infected participants must have CD4 counts above 350 cells/µL 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 reliable method of pregnancy prevention
You will not qualify if you...
- Acute illness
- Fever over 38.0 degrees centigrade
- Receiving any lipid-lowering agent currently, within three months prior, or likely to require one soon
- Known allergy or contraindication to atorvastatin or other statins
- Evidence of drug-resistant tuberculosis
- Extrapulmonary tuberculosis, including pleural TB or large pleural effusion
- Pregnant or planning pregnancy within the next 6 months
- Unable to take oral medications
- Diabetes defined by HbA1c ≥6.5, random glucose ≥200 mg/dL, fasting plasma glucose ≥126 mg/dL, or use of any anti-diabetic medication
- 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 within the previous 3 months
- Alcohol or substance abuse that might affect medication adherence
- Any condition the physician deems makes the study inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 12 weeks of daily oral atorvastatin or placebo to reduce persistent lung inflammation after tuberculosis treatment completion.
Weekly visits for up to 12 weeks
Duration - Up to 12 weeks
Participants are monitored after completing the 12-week treatment to assess lung inflammation and safety.
1 visit (in-person)
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
S
Sandra Mukasa, MD
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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