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

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ClinicalTrials.gov Identifier: NCT02234492
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Gary Small, Ottawa Heart Institute Research Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Cardiovascular Disease (CVD) Drug: Rosuvastatin Phase 4

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
Study Start Date : September 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rosuvastatin
Rosuvastatin 10mg once daily for 6 months.
Drug: Rosuvastatin
Comparison of rosuvastatin to no rosuvastatin
Other Name: Crestor

No Intervention: No rosuvastatin
No rosuvastatin- this group will continue with their current medical therapy for 6 months.



Primary Outcome Measures :
  1. Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax). [ Time Frame: At baseline ]
    At baseline, correlation between CFR by MCE and vascular inflammation (TBRmax) by FDG-PET/CT will be assessed. We anticipate good overall concurrence.


Secondary Outcome Measures :
  1. Change in CFR [ Time Frame: At 6 months ]
    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.

  2. Change in TBRmax. [ Time Frame: At 6 months ]
    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.

  3. Change in neurocognitive function [ Time Frame: At 6 months ]
    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 .



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234492


Locations
Canada, Ontario
The Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1H 8L6
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Ontario HIV Treatment Network
Investigators
Study Director: Girish Dwivedi, MD MRCP PhD University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research
Principal Investigator: Gary Small, MD MRCP Ottawa Heart Institute Research Corporation

Responsible Party: Gary Small, Associate Professor in Cardiology and Clinician Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02234492     History of Changes
Other Study ID Numbers: 20140263-01H
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gary Small, Ottawa Heart Institute Research Corporation:
Human immunodeficiency virus (HIV)
Statin therapy
Cardiovascular disease (CVD)
Coronary Flow Reserve (CFR)
Positron Emission Tomography (PET)
Myocardial contrast echocardiography (MCE)

Additional relevant MeSH terms:
Cardiovascular Diseases
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors