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Statin Therapy to Improve Atherosclerosis in HIV Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00965185
First received: August 24, 2009
Last updated: February 17, 2015
Last verified: February 2015
Results First Received: January 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[units: participants]
  19     21     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     21     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 3.8     50.0  ± 5.6     51.1  ± 4.9  
Gender  
[units: participants]
     
Female     4     4     8  
Male     15     17     32  
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:   Immune Function   [ Time Frame: Measured at baseline and 1 year ]

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

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

6.  Secondary:   Liver Function Tests (LFTs)   [ Time Frame: Measured at baseline, 1, 3, 6, 9, and 12 months ]

7.  Secondary:   Endothelial Function   [ Time Frame: Measured at 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Adipocytokines   [ Time Frame: Measured at 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 in assessing identical regions of aortic arterial inflammation in serial FDG-PET scans.


  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:

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00965185     History of Changes
Other Study ID Numbers: 2008-P-000257, R01HL095123, HL 095123
Study First Received: August 24, 2009
Results First Received: January 30, 2015
Last Updated: February 17, 2015
Health Authority: United States: Federal Government