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

October 3, 2018 updated by: Gary Small, Ottawa Heart Institute Research Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital-General Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rosuvastatin
Rosuvastatin 10mg once daily for 6 months.
Drug: Rosuvastatin
Comparison of rosuvastatin to no rosuvastatin
Other Names:
  • Crestor
No Intervention: No rosuvastatin
No rosuvastatin- this group will continue with their current medical therapy for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 months
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.
At 6 months
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 .
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140263-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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