Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Trial Parameters
Brief 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.
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 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, stor