Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Tuberculosis, Pulmonary

In brief

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.

Key facts

Study ID

NCT04147286

Run by

University of Cape Town

People needed

220

Starts

2020-07-14

Expected to finish

2027-09-30

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• General Medicine & Global Health, Cape Heart Institute, Faculty of Health Sciences, University of Cape Town — Observatory, WC, South Africa (enrolling)

Full record on ClinicalTrials.gov

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