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

University of Ottawa Heart Institute

Status and phase

Completed

Phase 4

Conditions

Cardiovascular Disease (CVD)

Human Immunodeficiency Virus (HIV)

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02234492

20140263-01H

Details and patient eligibility

About

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.

Full description

HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular disease (CVD) which may be related to this state of chronic inflammation. HIV infected individuals are at up to four times higher risk of suffering a heart attack (also know as acute coronary syndrome).

The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce inflammation in arteries in the general population and also in patients with high risk for heart problems.

72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.

Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6 months in addition to their current medical therapy.

Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will continue with their current medical therapy.

Participants in both groups will undergo blood tests, Myocardial Contrast Echocardiography (MCE) scan and a Positron Emission Tomography/Computed Tomography PET/CT scan using a radioactive tracer called fluorodeoxyglucose (FDG-PET), monocyte and serum cytokine studies at baseline and 6 months.

10 subjects without HIV will also be enrolled to undergo monocyte and serum cytokine blood tests only, for comparison.

Enrollment

35 patients

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

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