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Trial record 23 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Effect of Rosuvastatin on Endothelial Function

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ClinicalTrials.gov Identifier: NCT00986999
Recruitment Status : Terminated (poor enrollment)
First Posted : September 30, 2009
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Cardiovascular Disease
Intervention Drug: rosuvastatin
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rosuvastatin
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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

Period Title: Overall Study
Started 7
Completed 6
Not Completed 1
Arm/Group Title Rosuvastatin
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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

Overall Number of Baseline Participants 7
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  85.7%
>=65 years
1
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  42.9%
Native Hawaiian or Other Pacific Islander
1
  14.3%
Black or African American
0
   0.0%
White
3
  42.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Change in Flow Mediated Dilatation (FMD) of the Brachial Artery
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
Not analyzed
Arm/Group Title Rosuvastatin
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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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Total, HDL and LDL Cholesterol and Triglyceride Levels
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in hsCRP
Hide Description [Not Specified]
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosuvastatin
Hide Arm/Group Description

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

All-Cause Mortality
Rosuvastatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rosuvastatin
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosuvastatin
Affected / at Risk (%)
Total   0/7 (0.00%) 
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
Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT00986999     History of Changes
Other Study ID Numbers: H002
R01HL095135 ( U.S. NIH Grant/Contract )
First Submitted: September 29, 2009
First Posted: September 30, 2009
Results First Submitted: January 20, 2015
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015