About The Study
This study sought to determine if HIV positive individuals, who have high lipid levels, will benefit from the addition of a second lipid-lowering drug (ezetimibe) to existing lipid lowering therapy with a statin — chlorestoral lowering drug — (specifically rosuvastatin). The study compared the addition of ezetimibe with rosuvastatin, against increasing the dose of the ongoing statin.
Researchers measured improvements in the parameters of serum lipid — the fat separated from clotted blood, (namely total cholesterol, LDL, HDL, triglycerides and apolipoprotein B100 (apoB), apolipoprotein A1 (apoA1), apoB/apoA1 ratio) in both instances.
Study Approach
This study recruited a total of 50 HIV+ individuals with hypercholesterolemia (high blood cholesterol) due to highly active antiretroviral therapy. All participants who were already taking 10 mg of rosuvastatin and did not reaching lipid targets were randomized into one of two groups (25 individuals each).
Group 1: received an increased dose of rosuvastatin (20mg)
Group 2: received 10mg ezetimibe in addition to their ongoing rosuvastatin therapy
Study Approach
Researchers believed that the combination of rosuvastatin and ezetimibe could lower serum apolipoprotein B more so than an increased dose of rosuvastatin alone, in participants with mixed dyslipidemia associated with HIV therapy.
Secondarily, researchers believed the combination of rosuvastatin and ezetimibe could lower the concentrations of serum cholesterol, LDL-cholesterol, triglycerides, apolipoprotein B/apolipoprotein A1 ratio and C-reactive protein more so than an increased dose of rosuvastatin alone.
This trial is also listed on Clinicaltrials.gov
Eligibility Requirements
Required
- Be 19 years or older
- HIV-positive
- Currently taking 10mg of rosuvastatin
- Recent (within three months) fasting lipid profile in which the serum apolipoprotein B is >0.90
Participating Sites