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
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.
• 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
• Laboratory parameters within 30 days before enrolment:
• 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
• AST and ALT \<3x upper limit of normal (ULN)
• Creatinine \<2x ULN
⁃ Hemoglobin \>7.0 g/dL
⁃ Platelet count \>50 x109 cells/L
⁃ Creatinine kinase \<2x ULN
⁃ Able and willing to return to follow-up
⁃ Willing to have samples, including DNA, stored
⁃ Willing to consistently practice a highly reliable method of pregnancy prevention