Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Rosuvastatin on Endothelial Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Hawaii.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00986999
First received: September 29, 2009
Last updated: June 14, 2012
Last verified: June 2012

September 29, 2009
June 14, 2012
September 2009
August 2013   (final data collection date for primary outcome measure)
Change in flow mediated dilatation (FMD) of the brachial artery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in flow mediated dilatation (FMD) of the brachial artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00986999 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in glucose homeostasis and insulin resistance as assessed by oral glucose tolerance testing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in total, HDL and LDL cholesterol and triglyceride levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in hsCRP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: No ]
  • Change in glucose homeostasis and insulin resistance as assessed by oral glucose tolerance testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in total, trunk, and peripheral fat by dual energy absorptiometry (DXA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in total, HDL and LDL cholesterol and triglyceride levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in coronary calcium scores by CT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Occurrence of adverse side effects [as assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Dec. 2004)] [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Change in hsCRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Cardiovascular Disease
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
Experimental: rosuvastatin
rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
Intervention: Drug: rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Lorna Nagamine, RN 808 737-2751 ext 503
United States
 
NCT00986999
H002, R01HL095135
No
University of Hawaii
University of Hawaii
Not Provided
Principal Investigator: Cecilia Shikuma, MD Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii
University of Hawaii
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP