The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Ontario HIV Treatment Network
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 40-90 years of age

• documented evidence of HIV infection

• on standard antiretroviral therapy(ART) for >1 years

• viral load persistently below the limits of detection while on ART

• current Cluster of Differentiation Antigen 4 (CD4) count >350 cells/microlitre

• baseline Framingham risk score of 10-20%

Exclusion Criteria:

• uncontrolled diabetes mellitus (glycated hemoglobin (HbA1C) >6.5% or fasting glucose >7.0 mmol/L)

• uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >90)

• known coronary artery disease (CAD) e.g. previous myocardial infarction, revascularization procedure, or history of angina

• chronic renal failure (glomerular filtration rate (GFR) <60 ml/min)

• total cholesterol >5.8 mmol/L

• Low-density lipoprotein (LDL) cholesterol >4.0 mmol/L

• already receiving a statin for baseline dyslipidemia

• pregnant or lactating

• active untreated Hepatitis B or C

• diagnosis or clinical evidence of a concomitant inflammatory/autoimmune disease

• patients at baseline demonstrating regional perfusion abnormalities (confined to individual coronary territories) following stress MCE will be excluded and further management will be according to local best practice guidelines