Effect of Rosuvastatin on Endothelial Function

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00986999
First received: September 29, 2009
Last updated: January 20, 2015
Last verified: January 2015
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Cardiovascular Disease
Intervention: Drug: rosuvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rosuvastatin

rosuvastatin 10 mg qd increased to 20 mg qd as tolerated

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


Participant Flow:   Overall Study
    Rosuvastatin  
STARTED     7  
COMPLETED     6  
NOT COMPLETED     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rosuvastatin

rosuvastatin 10 mg qd increased to 20 mg qd as tolerated

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


Baseline Measures
    Rosuvastatin  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     1  
Gender  
[units: participants]
 
Female     0  
Male     7  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     0  
White     3  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing   [ Time Frame: 3 months ]

5.  Secondary:   Change in Total, HDL and LDL Cholesterol and Triglyceride Levels   [ Time Frame: 3 months ]

6.  Secondary:   Change in hsCRP   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Cecilia M. Shikuma M.D.
Organization: University of Hawaii
phone: 808 692-1328
e-mail: shikuma@hawaii.edu


No publications provided


Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT00986999     History of Changes
Other Study ID Numbers: H002, R01HL095135
Study First Received: September 29, 2009
Results First Received: January 20, 2015
Last Updated: January 20, 2015
Health Authority: United States: Institutional Review Board