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Cardiovascular Prevention for Persons With HIV

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ClinicalTrials.gov Identifier: NCT00982189
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : April 18, 2012
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Hide Arm/Group Description Lisinopril 10mg and placebo (matched to pravastatin) once daily Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily Lisinopril 10mg and Pravastatin 20mg once daily Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
Period Title: Overall Study
Started 10 9 9 9
Completed 10 9 9 9
Not Completed 0 0 0 0
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo Total
Hide Arm/Group Description Lisinopril 10mg and placebo (matched to pravastatin) once daily Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily Lisinopril 10mg and Pravastatin 20mg once daily Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily Total of all reporting groups
Overall Number of Baseline Participants 10 9 9 9 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 9 participants 9 participants 37 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 9 participants 9 participants 37 participants
52  (8) 47  (12) 48  (4) 45  (7) 48  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 9 participants 9 participants 37 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 9 participants 9 participants 37 participants
10 9 9 9 37
1.Primary Outcome
Title Number of Participants Who Stated (by Self-report) That They Had Side Effects
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants who stated (by self-report) that they had side effects
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Hide Arm/Group Description:
Lisinopril 10mg and placebo (matched to pravastatin) once daily
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril 10mg and Pravastatin 20mg once daily
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
Overall Number of Participants Analyzed 10 9 9 9
Measure Type: Number
Unit of Measure: participants
1 0 2 1
2.Primary Outcome
Title Number of Participants Who Took >90% of Their Doses (by Pill Count)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Hide Arm/Group Description:
Lisinopril 10mg and placebo (matched to pravastatin) once daily
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril 10mg and Pravastatin 20mg once daily
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
Overall Number of Participants Analyzed 4 7 8 6
Measure Type: Number
Unit of Measure: participants
2 7 5 6
3.Primary Outcome
Title Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Hide Arm/Group Description:
Lisinopril 10mg and placebo (matched to pravastatin) once daily
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
Lisinopril 10mg and Pravastatin 20mg once daily
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
Overall Number of Participants Analyzed 10 9 9 9
Median (Inter-Quartile Range)
Unit of Measure: Percent probability of CHD event in 10yr
-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)
4.Secondary Outcome
Title Changes in Blood Pressure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Lisinopril/L-placebo Treatment Effect
Hide Arm/Group Description:
Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
Overall Number of Participants Analyzed 34
Mean (95% Confidence Interval)
Unit of Measure: (mmHG)
Systolic BP
-1.8
(-9.4 to 5.8)
Diastolic BP
-3.3
(-7.3 to 0.7)
5.Secondary Outcome
Title Changes in Blood Lipids
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Pravastatin/P-placebo Treatment Effect
Hide Arm/Group Description:
Pravastatin vs. Pravastatin-placebo (regardless of Lisinopril status)
Overall Number of Participants Analyzed 34
Mean (95% Confidence Interval)
Unit of Measure: (mg/dL)
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)
6.Secondary Outcome
Title Changes in Small Artery Elasticity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Lisinopril/L-placebo Treatment Effect
Hide Arm/Group Description:
Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
Overall Number of Participants Analyzed 34
Mean (Standard Error)
Unit of Measure: mL/mmHgx100
0.02  (0.75)
7.Secondary Outcome
Title Changes hsCRP (C-reactive Protein)
Hide Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Lisinopril/L-placebo Treatment Effect
Hide Arm/Group Description:
Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
Overall Number of Participants Analyzed 34
Geometric Mean (Standard Error)
Unit of Measure: mcg/mL
-1.00  (0.40)
8.Secondary Outcome
Title Changes IL-6 (Interleukin-6)
Hide Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Lisinopril/L-placebo Treatment Effect
Hide Arm/Group Description:
Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
Overall Number of Participants Analyzed 34
Geometric Mean (Standard Error)
Unit of Measure: pg/mL
-0.33  (0.24)
9.Secondary Outcome
Title Changes TNFa (Tumor Necrosis Factor Alpha)
Hide Description This biomarker represents systemic inflammation within in the body.
Time Frame change from baseline to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Lisinopril/L-placebo Treatment Effect
Hide Arm/Group Description:
Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
Overall Number of Participants Analyzed 34
Geometric Mean (Standard Error)
Unit of Measure: pg/mL
-0.14  (0.10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Hide Arm/Group Description Lisinopril 10mg and placebo (matched to pravastatin) once daily Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily Lisinopril 10mg and Pravastatin 20mg once daily Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
All-Cause Mortality
Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lisinopril/P-placebo L-placebo/Pravastatin Lisinopril/Pravastatin L-placebo/P-placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Study was small with limited power to detect differences.
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
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