NCT00986999

Effect of Rosuvastatin on Endothelial Function

Pilot Study of the Effect of Low-Dose Rosuvastatin on Endothelial Function, Oxidative Stress and Inflammatory Parameters in HIV-Infected Individuals With Low HDL Cholesterol Levels and Low to Normal LDL Cholesterol Levels

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins. The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).

Conditions

• HIV Infections
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	rosuvastatin	rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-01-01
• First posted: 2009-09-30
• Last updated: 2015-01-29
• Results posted: 2015-01-29

Locations

1 site across 1 country: United States