Human Immunodeficiency Virus (HIV)Phase 4NCT02234492
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
A Phase 4 study testing Rosuvastatin in people with Human Immunodeficiency Virus (HIV) and Cardiovascular Disease (CVD), run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Cardiovascular Disease (CVD)
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2014to Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
About this study
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.
Read the 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.
- Being tested
- Rosuvastatin
- Keywords
- Human immunodeficiency virus (HIV), Statin therapy, Cardiovascular disease (CVD), Coronary Flow Reserve (CFR), Positron Emission Tomography (PET), Myocardial contrast echocardiography (MCE)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Comparison of rosuvastatin to no rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Rosuvastatin 10mg once daily for 6 months. Receives: Drug: Rosuvastatin |
| No rosuvastatin | No intervention | No rosuvastatin- this group will continue with their current medical therapy for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (3)
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.
Measured: At 6 months
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.
Measured: At 6 months
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 .
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Responsible party
- Principal investigator, Gary Small, Ottawa Heart Institute Research Corporation
- Investigators
- Girish Dwivedi, MD MRCP PhD, Study director, University of Ottawa Heart Institute, Harry Perkins Institute of Medical ResearchGary Small, MD MRCP, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234492
- Sponsor's protocol ID
- 20140263-01H
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
- ClinicalTrials.gov ID
- NCT02234492
- Acronym / sponsor ID
- 20140263-01H
- Keywords
- Human immunodeficiency virus (HIV), Statin therapy, Cardiovascular disease (CVD), Coronary Flow Reserve (CFR), Positron Emission Tomography (PET), Myocardial contrast echocardiography (MCE)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Study start
- Sep 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin 10mg once daily for 6 months. |
| No rosuvastatin | No intervention | –No rosuvastatin- this group will continue with their current medical therapy for 6 months. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorComparison of rosuvastatin to no rosuvastatin | Drug | Rosuvastatin |
Primary outcome
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.
3 secondary outcomes
Change in CFR
Time frame: At 6 months
Change in TBRmax.
Time frame: At 6 months
Change in neurocognitive function
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Girish Dwivedi, MD MRCP PhD study director
University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research
Gary Small, MD MRCP principal investigator
Ottawa Heart Institute Research Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Human Immunodeficiency Virus (HIV) and Cardiovascular Disease (CVD), run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax). (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.