NCT02234492

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Human Immunodeficiency Virus (HIV)
• Cardiovascular Disease (CVD)

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Comparison of rosuvastatin to no rosuvastatin

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2014-09-09
• Last updated: 2018-10-05

Locations

2 sites across 1 country: Canada