Trial Outcomes & Findings for Cardiovascular Prevention for Persons With HIV (NCT NCT00982189)
NCT ID: NCT00982189
Last Updated: 2017-11-22
Results Overview
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.
COMPLETED
NA
37 participants
4 months
2017-11-22
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular Prevention for Persons With HIV
Baseline characteristics by cohort
| Measure |
Lisinopril/P-placebo
n=10 Participants
Lisinopril 10mg and placebo (matched to pravastatin) once daily
|
L-placebo/Pravastatin
n=9 Participants
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
|
Lisinopril/Pravastatin
n=9 Participants
Lisinopril 10mg and Pravastatin 20mg once daily
|
L-placebo/P-placebo
n=9 Participants
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 8 • n=5 Participants
|
47 years
STANDARD_DEVIATION 12 • n=7 Participants
|
48 years
STANDARD_DEVIATION 4 • n=5 Participants
|
45 years
STANDARD_DEVIATION 7 • n=4 Participants
|
48 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Number of participants who stated (by self-report) that they had side effects
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.
Outcome measures
| Measure |
Lisinopril/P-placebo
n=10 Participants
Lisinopril 10mg and placebo (matched to pravastatin) once daily
|
L-placebo/Pravastatin
n=9 Participants
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
|
Lisinopril/Pravastatin
n=9 Participants
Lisinopril 10mg and Pravastatin 20mg once daily
|
L-placebo/P-placebo
n=9 Participants
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
|
|---|---|---|---|---|
|
Number of Participants Who Stated (by Self-report) That They Had Side Effects
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 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
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'
Outcome measures
| Measure |
Lisinopril/P-placebo
n=4 Participants
Lisinopril 10mg and placebo (matched to pravastatin) once daily
|
L-placebo/Pravastatin
n=7 Participants
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
|
Lisinopril/Pravastatin
n=8 Participants
Lisinopril 10mg and Pravastatin 20mg once daily
|
L-placebo/P-placebo
n=6 Participants
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
|
|---|---|---|---|---|
|
Number of Participants Who Took >90% of Their Doses (by Pill Count)
|
2 participants
|
7 participants
|
5 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Change from baseline to 4 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Lisinopril/P-placebo
n=10 Participants
Lisinopril 10mg and placebo (matched to pravastatin) once daily
|
L-placebo/Pravastatin
n=9 Participants
Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
|
Lisinopril/Pravastatin
n=9 Participants
Lisinopril 10mg and Pravastatin 20mg once daily
|
L-placebo/P-placebo
n=9 Participants
Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
|
|---|---|---|---|---|
|
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
|
-1.6 Percent probability of CHD event in 10yr
Interval -2.3 to 1.1
|
-0.7 Percent probability of CHD event in 10yr
Interval -2.6 to 0.4
|
-1.5 Percent probability of CHD event in 10yr
Interval -2.1 to 0.5
|
-0.3 Percent probability of CHD event in 10yr
Interval -0.7 to 0.2
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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).
Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes in Blood Pressure
Systolic BP
|
-1.8 (mmHG)
Interval -9.4 to 5.8
|
—
|
—
|
—
|
|
Changes in Blood Pressure
Diastolic BP
|
-3.3 (mmHG)
Interval -7.3 to 0.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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).
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
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes in Blood Lipids
HDL-C
|
0.97 (mg/dL)
Interval -8.42 to 10.36
|
—
|
—
|
—
|
|
Changes in Blood Lipids
Total Cholesterol
|
-1.75 (mg/dL)
Interval -18.74 to 15.25
|
—
|
—
|
—
|
|
Changes in Blood Lipids
LDL-C
|
-0.62 (mg/dL)
Interval -13.22 to 11.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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
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.
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes in Small Artery Elasticity
|
0.02 mL/mmHgx100
Standard Error 0.75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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
This biomarker represents systemic inflammation within in the body.
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes hsCRP (C-reactive Protein)
|
-1.00 mcg/mL
Standard Error 0.40
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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
This biomarker represents systemic inflammation within in the body.
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes IL-6 (Interleukin-6)
|
-0.33 pg/mL
Standard Error 0.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: change from baseline to 4 monthsPopulation: 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
This biomarker represents systemic inflammation within in the body.
Outcome measures
| Measure |
Lisinopril/P-placebo
n=34 Participants
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
|
|---|---|---|---|---|
|
Changes TNFa (Tumor Necrosis Factor Alpha)
|
-0.14 pg/mL
Standard Error 0.10
|
—
|
—
|
—
|
Adverse Events
Lisinopril/P-placebo
L-placebo/Pravastatin
Lisinopril/Pravastatin
L-placebo/P-placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place