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Cardiovascular Prevention for Persons With HIV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982189
First Posted: September 23, 2009
Last Update Posted: November 22, 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:
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      9 100.0%      9 100.0%      9 100.0%      37 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (8)   47  (12)   48  (4)   45  (7)   48  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      1  11.1%      0   0.0%      0   0.0%      1   2.7% 
Male      10 100.0%      8  88.9%      9 100.0%      9 100.0%      36  97.3% 
Region of Enrollment 
[Units: Participants]
         
United States   10   9   9   9   37 


  Outcome Measures
  Hide All Outcome Measures

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

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 ]

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  

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 
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 ]

Measure Type Primary
Measure Title Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
Measure Description The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
Time Frame Change from baseline to 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.
All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.

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 
Change From Baseline to Month 4 in the Framingham Risk Score (FRS) 
[Units: Percent probability of CHD event in 10yr]
Median (Inter-Quartile Range)
 -1.6 
 (-2.3 to 1.1) 
 -0.7 
 (-2.6 to 0.4) 
 -1.5 
 (-2.1 to 0.5) 
 -0.3 
 (-0.7 to 0.2) 

No statistical analysis provided for Change From Baseline to Month 4 in the Framingham Risk Score (FRS)



4.  Secondary:   Changes in Blood Pressure   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes in Blood Pressure
Measure Description Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)
Time Frame change from baseline to 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.
n=17 Lisinopril vs. n=17 L-placebo The outcome is analyzed as the 'main effect' for lisinopril versus placebo, as standard for factorial study designs. Since lisinopril, but not pravastatin, influences blood pressure, the analysis defines Lisinopril and L-placebo groups by pooling across pravastatin groups (i.e., P-placebo + Pravastatin groups).

Reporting Groups
  Description
Lisinopril/L-placebo Treatment Effect Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)

Measured Values
   Lisinopril/L-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes in Blood Pressure 
[Units: (mmHG)]
Mean (95% Confidence Interval)
 
Systolic BP   -1.8 
 (-9.4 to 5.8) 
Diastolic BP   -3.3 
 (-7.3 to 0.7) 

No statistical analysis provided for Changes in Blood Pressure



5.  Secondary:   Changes in Blood Lipids   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes in Blood Lipids
Measure Description Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides
Time Frame change from baseline to 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.
n = 18 Pravastatin vs. n = 16 P-placebo The outcome is analyzed as the 'main effect' for pravastatin versus placebo, as standard for factorial study designs. Since pravastatin, but not lisinopril, influences cholesterol, the analysis defines Pravastatin and P-placebo groups by pooling across lisinopril groups (i.e., L-placebo + Lisinopril group).

Reporting Groups
  Description
Pravastatin/P-placebo Treatment Effect Pravastatin vs. Pravastatin-placebo (regardless of Lisinopril status)

Measured Values
   Pravastatin/P-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes in Blood Lipids 
[Units: (mg/dL)]
Mean (95% Confidence Interval)
 
Total Cholesterol   -1.75 
 (-18.74 to 15.25) 
LDL-C   -0.62 
 (-13.22 to 11.98) 
HDL-C   0.97 
 (-8.42 to 10.36) 

No statistical analysis provided for Changes in Blood Lipids



6.  Secondary:   Changes in Small Artery Elasticity   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes in Small Artery Elasticity
Measure Description Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.
Time Frame change from baseline to 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.
Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4

Reporting Groups
  Description
Lisinopril/L-placebo Treatment Effect Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)

Measured Values
   Lisinopril/L-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes in Small Artery Elasticity 
[Units: mL/mmHgx100]
Mean (Standard Error)
 0.02  (0.75) 

No statistical analysis provided for Changes in Small Artery Elasticity



7.  Secondary:   Changes hsCRP (C-reactive Protein)   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes hsCRP (C-reactive Protein)
Measure Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 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.
Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4

Reporting Groups
  Description
Lisinopril/L-placebo Treatment Effect Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)

Measured Values
   Lisinopril/L-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes hsCRP (C-reactive Protein) 
[Units: mcg/mL]
Geometric Mean (Standard Error)
 -1.00  (0.40) 

No statistical analysis provided for Changes hsCRP (C-reactive Protein)



8.  Secondary:   Changes IL-6 (Interleukin-6)   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes IL-6 (Interleukin-6)
Measure Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 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.
Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4

Reporting Groups
  Description
Lisinopril/L-placebo Treatment Effect Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)

Measured Values
   Lisinopril/L-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes IL-6 (Interleukin-6) 
[Units: pg/mL]
Geometric Mean (Standard Error)
 -0.33  (0.24) 

No statistical analysis provided for Changes IL-6 (Interleukin-6)



9.  Secondary:   Changes TNFa (Tumor Necrosis Factor Alpha)   [ Time Frame: change from baseline to 4 months ]

Measure Type Secondary
Measure Title Changes TNFa (Tumor Necrosis Factor Alpha)
Measure Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 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.
Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4

Reporting Groups
  Description
Lisinopril/L-placebo Treatment Effect Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)

Measured Values
   Lisinopril/L-placebo Treatment Effect 
Participants Analyzed 
[Units: Participants]
 34 
Changes TNFa (Tumor Necrosis Factor Alpha) 
[Units: pg/mL]
Geometric Mean (Standard Error)
 -0.14  (0.10) 

No statistical analysis provided for Changes TNFa (Tumor Necrosis Factor Alpha)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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: Dr. Jason Baker
Organization: Minneapolis Medical Foundation
phone: 612-873-2705
e-mail: baker459@umn.edu


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

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00982189     History of Changes
Other Study ID Numbers: PCC-003
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: January 16, 2012
Results First Posted: April 18, 2012
Last Update Posted: November 22, 2017