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

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234492
• Other study ID #: 20140263-01H
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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 in?ammatory/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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiovascular Disease (CVD)
• Cardiovascular Diseases
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Rosuvastatin
Comparison of rosuvastatin to no rosuvastatin

Locations

Country	Name	City	State
Canada	The Ottawa Hospital-General Campus	Ottawa	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax).	At baseline, correlation between CFR by MCE and vascular inflammation (TBRmax) by FDG-PET/CT will be assessed. We anticipate good overall concurrence.	At baseline
Secondary	Change in CFR	Changes in CFR as measured by MCE will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin. Our study will be one of the first to examine the effects of rosuvastatin on measures of both inflammation and CFR in HIV+ patients.	At 6 months
Secondary	Change in TBRmax.	Changes in vascular inflammation (TBRmax) as measured by FDG-PET/CT will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin.	At 6 months
Secondary	Change in neurocognitive function	Changes in neurocognitve function as measured by a neuropsychological test battery (AMS-III Spatial Span, WAIS-R Digit Symbol, Hopkins Verbal Learning Test, Grooved Pegboard, Trail Making Tests A&B, Letter Numbering Sequencing , Patient's Assessment of Own Functioning, Center for Epidemiologic Studies-Depression Scale) will be evaluated over six months .	At 6 months