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Statin Therapy to Improve Atherosclerosis in HIV Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965185
First Posted: August 25, 2009
Last Update Posted: November 9, 2017
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
Results First Submitted: January 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cardiovascular Disease
HIV
Atherosclerosis
Inflammation
Statins, HMG-CoA
HIV Infections
Interventions: Drug: atorvastatin
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
This study enrolled men and women with HIV disease, no history of cardiovascular disease or cardiac symptoms, and evidence of subclinical atherosclerosis at Massachusetts General Hospital in Boston, MA USA. The study was done from November, 2009 to January, 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 81 patients screened for the study, 40 completed the screening and were randomized to the two study arms.

Reporting Groups
  Description
Atorvastatin Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
Placebo Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.

Participant Flow:   Overall Study
    Atorvastatin   Placebo
STARTED   19   21 
1 Month Visit   18   21 
3 Month Visit   18   21 
6 Month Visit   18   21 
9 Month Visit   18   21 
COMPLETED   17   20 
NOT COMPLETED   2   1 
Lost to Follow-up                2                0 
Withdrawal by Subject                0                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
Atorvastatin Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
Placebo Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
Total Total of all reporting groups

Baseline Measures
   Atorvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   21   40 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19 100.0%      21 100.0%      40 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (3.8)   50.0  (5.6)   51.1  (4.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  21.1%      4  19.0%      8  20.0% 
Male      15  78.9%      17  81.0%      32  80.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   13   13   26 
Black   3   3   6 
Asian   0   1   1 
Hispanic   1   1   2 
More than one race   2   1   3 
Unknown   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   19   21   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Coronary and Aortic Plaque Inflammation   [ Time Frame: Measured at baseline and 1 year ]

2.  Secondary:   Plaque Progression   [ Time Frame: Measured at baseline and 1 year ]

3.  Secondary:   Endothelial Function   [ Time Frame: 1 year ]

4.  Secondary:   Immune Function   [ Time Frame: Measured at baseline and 1 year ]

5.  Secondary:   Lipid Profile   [ Time Frame: Measured at baseline and 1 year ]

6.  Secondary:   C-reactive Protein (CRP)   [ Time Frame: Measured at baseline and 1 year ]

7.  Secondary:   Adipocytokines   [ Time Frame: Measured at baseline and 1 year ]

8.  Secondary:   Liver Function Tests (LFTs)   [ Time Frame: Measured at baseline, 1, 3, 6, 9, and 12 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
FDG-PET scan data was interpretable in only a limited subset of participants as a result of technical problems with manual co-registration (outcome 1). We were unable to collect data for endothelial function due to equipment malfunction (outcome 3).


  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: Dr. Steven K Grinspoon
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@mgh.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00965185     History of Changes
Other Study ID Numbers: 2008-P-000257
R01HL095123 ( U.S. NIH Grant/Contract )
HL 095123
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: January 30, 2015
Results First Posted: February 26, 2015
Last Update Posted: November 9, 2017