NCT02234492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

4.1 years

First QC Date

August 20, 2014

Last Update Submit

October 3, 2018

Conditions

Human Immunodeficiency Virus (HIV)Cardiovascular Disease (CVD)

Keywords

Human immunodeficiency virus (HIV)Statin therapyCardiovascular disease (CVD)Coronary Flow Reserve (CFR)Positron Emission Tomography (PET)Myocardial contrast echocardiography (MCE)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in CFR

    At 6 months

  • Change in TBRmax.

    At 6 months

  • Change in neurocognitive function

    At 6 months

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin 10mg once daily for 6 months.

Drug: Rosuvastatin

No rosuvastatin

NO INTERVENTION

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

Interventions

RosuvastatinDRUG

Comparison of rosuvastatin to no rosuvastatin

Also known as: Crestor
Rosuvastatin

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCardiovascular Diseases

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Girish Dwivedi, MD MRCP PhD

    University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research

    STUDY DIRECTOR

  • Gary Small, MD MRCP

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Cardiology and Clinician Investigator

Study Record Dates

First Submitted

August 20, 2014

First Posted

September 9, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)