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Effect of Rosuvastatin on Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986999
Recruitment Status : Terminated (poor enrollment)
First Posted : September 30, 2009
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Information provided by (Responsible Party):
University of Hawaii

Brief 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).

Condition or disease Intervention/treatment Phase
HIV Infections Cardiovascular Disease Drug: rosuvastatin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rosuvastatin
rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
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
Other Name: Crestor

Primary Outcome Measures :
  1. Change in Flow Mediated Dilatation (FMD) of the Brachial Artery [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes [ Time Frame: 3 months ]
  2. Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels [ Time Frame: 3 months ]
  3. Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing [ Time Frame: 3 months ]
  4. Change in Total, HDL and LDL Cholesterol and Triglyceride Levels [ Time Frame: 3 months ]
  5. Change in hsCRP [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 </= 130 mg/dL
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986999

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United States, Hawaii
Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
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Principal Investigator: Cecilia Shikuma, MD Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii

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Responsible Party: University of Hawaii Identifier: NCT00986999     History of Changes
Other Study ID Numbers: H002
R01HL095135 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2009    Key Record Dates
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by University of Hawaii:
HIV infected
treatment experienced
Additional relevant MeSH terms:
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Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors