Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
AstraZeneca
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01218802
First received: October 8, 2010
Last updated: March 3, 2016
Last verified: March 2016
Results First Received: December 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: HIV Infections
Heart Disease
Interventions: Drug: Rosuvastatin 10 mg. daily for 96 weeks
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rosuvastatin

Participants will take Rosuvastatin 10 mg. daily for 96 weeks

Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.

Sugar Pill Placebo

Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.

Placebo: participants will take a sugar pill daily for 96 weeks


Participant Flow:   Overall Study
    Rosuvastatin     Sugar Pill Placebo  
STARTED     72     75  
COMPLETED     62     57  
NOT COMPLETED     10     18  
Lost to Follow-up                 5                 6  
Withdrawal by Subject                 3                 10  
Adverse Event                 0                 2  
Incarcerated                 2                 0  



  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

Participants will take Rosuvastatin 10 mg. daily for 96 weeks

Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.

Sugar Pill Placebo

Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.

Placebo: participants will take a sugar pill daily for 96 weeks

Total Total of all reporting groups

Baseline Measures
    Rosuvastatin     Sugar Pill Placebo     Total  
Number of Participants  
[units: participants]
  72     75     147  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     71     75     146  
>=65 years     1     0     1  
Age  
[units: years]
Mean (Standard Deviation)
  45  (9)     45  (10)     45  (9.8)  
Gender  
[units: participants]
     
Female     14     18     32  
Male     58     57     115  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     50     50     100  
White     20     23     43  
More than one race     1     1     2  
Unknown or Not Reported     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     72     75     147  
Mean HIV Duration  
[units: months]
Mean (Standard Deviation)
  140  (79)     152  (86)     146  (83)  
Mean ARV Duration  
[units: months]
Mean (Standard Deviation)
  84  (63)     87  (62)     86  (62)  
Undetectable Viral Load (<48)  
[units: participants]
  50     56     106  
Mean Absolute CD4 Count  
[units: 10^6 cells/L]
Mean (Standard Deviation)
  644  (285)     636  (312)     640  (299)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bone Mineral Density (BMD)   [ Time Frame: 96 weeks ]

2.  Primary:   Carotid IMT   [ Time Frame: 96 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Grace McComsey, MD
Organization: Case Western Reserve University
phone: 2168442739
e-mail: gam9@case.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01218802     History of Changes
Other Study ID Numbers: 1R01NR012642-01 ( US NIH Grant/Contract Award Number )
Study First Received: October 8, 2010
Results First Received: December 11, 2015
Last Updated: March 3, 2016
Health Authority: United States: Institutional Review Board