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RecruitingPhase 2Phase 3NCT04147286

Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion

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

Sponsor

University of Cape Town

Enrollment

220 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

Tuberculosis, Pulmonary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria16

  • 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

Exclusion Criteria14

  • Acute illness
  • Fever (temperature \>38.0 degrees centigrade)
  • 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
  • Evidence of drug-resistant TB
  • Extrapulmonary TB, including pleural TB and/or large pleural effusion
  • Pregnant or desiring/trying to become pregnant in the next 6 months
  • Unable to take oral medications
  • Diabetes as defined by point of care HbA1c≥6.5, random glucose≥200mg/dL (or 11.1mmol/L), fasting plasma glucose≥126mg/dL (or 7.0mmol/L), or the presence of any anti-diabetic agent (including traditional medicines) as a concomitant medicine
  • Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
  • Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
  • Use of any investigational drug in the previous 3 months
  • Alcohol and substance abuse which might interfere with medication adherence during the trial
  • Any person for whom the physician feels this study is not appropriate

Interventions

DRUGAtorvastatin 40mg

12 weeks of 40 mg atorvastatin therapy per os

DRUGPlacebo oral tablet

Identical placebo

Locations(1)

General Medicine & Global Health, Cape Heart Institute, Faculty of Health Sciences, University of Cape Town

Observatory, WC, South Africa

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NCT04147286