Effect of Rosuvastatin on Endothelial Function
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | September 2009 |
| End Date: | December 2013 |
| Contact: | Lorna Nagamine, RN |
| Phone: | 808 737-2751 |
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
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).
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).
Inclusion Criteria:
- HIV infection
- Age > 18 years old
- On stable antiretroviral therapy for > 6 months with no plans to change therapy
during the treatment phase of the study
- Plasma HIV RNA < 50 copies/mL
- Karnofsky performance score > 70 within 30 days prior to study entry
- Ability to understand and sign informed consent
- Following laboratory values obtained within 30 days prior to randomization:
- Absolute neutrophil count (ANC) > 750/mm3
- Hemoglobin >/= 8.0 g/dL
- Platelets >/= 50,000/mm3
- ALT (SGPT) and AST (SGOT) < 2.5 x ULN
- Fasting glucose < 126 mg/dL
- TSH < 3.0 mIU/L
- HDL-C < 50 mg/dL in men, < 55 mg/dL in women
- Direct LDL-C
- Calculated creatinine clearance > 50 mL/min
- Willing to be treated with rosuvastatin or be on an observational arm for a minimum
of 3 months
- Female subject must not participate in a conception process (active attempt to become
pregnant) or be post-menopausal. If participating in sexual activity that could lead
to pregnancy, the subject must use contraception while receiving study medication and
30 days after stopping the medication
Exclusion criteria
- History of past cardiovascular event
- Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days
prior to entry
- Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
- Serology positive for hepatitis B surface antigen or hepatitis C antibody
- Signs and symptoms of liver failure
- Receipt of supraphysiologic glucocorticoid therapy within 3 months prior to study
entry
- Use of lipid lowering agents within 30 days prior to study entry
- Receipt of an HIV vaccine or investigational agents
- Pregnancy or breast-feeding
- Presence of any active malignancy within the last 5 years
- Severe Hypertension (Systolic >/= 180 or Diastolic >/= 110 mm Hg)
- Use of oral postmenopausal hormone replacement therapy
- Known hypersensitivity to rosuvastatin
- Active drug or alcohol dependence
- Any acute illness within 30 days prior to study entry that, in the opinion of the
site investigator, would interfere with participation in the study.
- Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen
We found this trial at
1
site
Click here to add this to my saved trials
