Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion (NCT04147286) | Clinical Trial Compass
RecruitingPhase 2/3
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
South Africa220 participantsStarted 2020-07-14
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and 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
✓. 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/µL within 30 days prior to enrolment
✕. 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.
✕. Known allergy or contraindications to the investigational drug or any other statins