Cardiovascular Prevention for Persons With HIV (AHA pilot)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00982189
First received: September 22, 2009
Last updated: October 10, 2012
Last verified: October 2012
Results First Received: January 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: HIV Infection
Cardiovascular Disease Risk
Interventions: Drug: Pravastatin
Drug: Lisinopril

  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
Lisinopril/P-placebo Lisinopril 10mg and placebo (matched to pravastatin) once daily
L-placebo/Pravastatin Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril/Pravastatin Lisinopril 10mg and Pravastatin 20mg once daily
L-placebo/P-placebo Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily

Participant Flow:   Overall Study
    Lisinopril/P-placebo     L-placebo/Pravastatin     Lisinopril/Pravastatin     L-placebo/P-placebo  
STARTED     10     9     9     9  
COMPLETED     10     9     9     9  
NOT COMPLETED     0     0     0     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
Lisinopril/P-placebo Lisinopril 10mg and placebo (matched to pravastatin) once daily
L-placebo/Pravastatin Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril/Pravastatin Lisinopril 10mg and Pravastatin 20mg once daily
L-placebo/P-placebo Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
Total Total of all reporting groups

Baseline Measures
    Lisinopril/P-placebo     L-placebo/Pravastatin     Lisinopril/Pravastatin     L-placebo/P-placebo     Total  
Number of Participants  
[units: participants]
  10     9     9     9     37  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     9     9     9     37  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 8     47  ± 12     48  ± 4     45  ± 7     48  ± 7  
Gender  
[units: participants]
         
Female     0     1     0     0     1  
Male     10     8     9     9     36  
Region of Enrollment  
[units: participants]
         
United States     10     9     9     9     37  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Stated (by Self-report) That They Had Side Effects   [ Time Frame: 4 months ]

2.  Primary:   Number of Participants Who Took >90% of Their Doses (by Pill Count)   [ Time Frame: 4 months ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Number of Participants Who Took >90% of Their Doses (by Pill Count)
Measure Description The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'
Time Frame 4 months  
Safety Issue No  

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.
Number of participants who took >90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses

Reporting Groups
  Description
Lisinopril/P-placebo Lisinopril 10mg and placebo (matched to pravastatin) once daily
L-placebo/Pravastatin Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril/Pravastatin Lisinopril 10mg and Pravastatin 20mg once daily
L-placebo/P-placebo Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily

Measured Values
    Lisinopril/P-placebo     L-placebo/Pravastatin     Lisinopril/Pravastatin     L-placebo/P-placebo  
Number of Participants Analyzed  
[units: participants]
  4     7     8     6  
Number of Participants Who Took >90% of Their Doses (by Pill Count)  
[units: participants]
  2     7     5     6  

No statistical analysis provided for Number of Participants Who Took >90% of Their Doses (by Pill Count)



3.  Primary:   Change From Baseline to Month 4 in the Framingham Risk Score (FRS)   [ Time Frame: Change from baseline to 4 months ]

4.  Secondary:   Changes in Blood Pressure   [ Time Frame: change from baseline to 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Blood Lipids   [ Time Frame: change from baseline to 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Small Artery Elasticity   [ Time Frame: change from baseline to 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Changes in Biomarkers   [ Time Frame: change from baseline to 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
Study was small with limited power to detect differences.  


Results Point of Contact:  
Name/Title: Dr. Jason Baker
Organization: Minneapolis Medical Foundation
phone: 612-873-2705
e-mail: baker459@umn.edu


No publications provided by Minneapolis Medical Research Foundation

Publications automatically indexed to this study:

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00982189     History of Changes
Other Study ID Numbers: PCC-003
Study First Received: September 22, 2009
Results First Received: January 16, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board