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Cardiovascular Prevention for Persons With HIV (AHA pilot)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982189
First Posted: September 23, 2009
Last Update Posted: October 12, 2012
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:
American Heart Association
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
Results First Submitted: January 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Number of Participants Who Stated (by Self-report) That They Had Side Effects
Measure Description Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.
Time Frame 4 months  

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 stated (by self-report) that they had side effects

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 
Participants Analyzed 
[Units: Participants]
 10   9   9   9 
Number of Participants Who Stated (by Self-report) That They Had Side Effects 
[Units: Participants]
 1   0   2   1 

No statistical analysis provided for Number of Participants Who Stated (by Self-report) That They Had Side Effects



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

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 reported.   Anticipated Reporting Date:   No text entered.  

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

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

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


  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
Study was small with limited power to detect differences.


  More Information