About The Study

This study seeks 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 will compare the addition of ezetimibe with rosuvastatin, against increasing the dose of the ongoing statin.

Researchers will measure 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 will recruit a total of 50 HIV+ individuals with hypercholesterolemia (high blood cholesterol) due to highly active antiretroviral therapy. All participants who are already taking 10 mg of rosuvastatin and are not reaching lipid targets will be randomized into one of two groups (25 individuals each).
Group 1: will receive an increased dose of rosuvastatin (20mg)
Group 2: will receive 10mg ezetimibe in addition to their ongoing rosuvastatin therapy

Study Approach

Researchers believe that the combination of rosuvastatin and ezetimibe will lower serum apolipoprotein B more so than an increased dose of rosuvastatin alone, in participants with mixed dyslipidemia associated with HIV therapy.

Secondarily, researchers believe the combination of rosuvastatin and ezetimibe will 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

Here’s where this study is being conducted.