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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).
Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisinopril | Experimental | Lisinopril 10mg once daily |
|
| Lisinopril Placebo | Placebo Comparator | Placebo pill (matched to lisinopril) once daily |
|
| Pravastatin | Experimental | Pravastatin 20mg once daily |
|
| Pravastatin placebo | Placebo Comparator | Placebo pill (matched to pravastatin) once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | Participants randomized to take pravastatin (active) or matching placebo pill once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Number of Participants Who Took >90% of Their Doses (by Pill Count) | 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' | 4 months |
| Change From Baseline to Month 4 in the Framingham Risk Score (FRS) | 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) | Change from baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Blood Pressure | Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit) | change from baseline to 4 months |
| Changes in Blood Lipids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Baker, MD | Hennepin Faculty Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23082133 | Derived | Baker JV, Huppler Hullsiek K, Prosser R, Duprez D, Grimm R, Tracy RP, Rhame F, Henry K, Neaton JD. Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial. PLoS One. 2012;7(10):e46894. doi: 10.1371/journal.pone.0046894. Epub 2012 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisinopril/P-placebo | Lisinopril 10mg and placebo (matched to pravastatin) once daily |
| FG001 | L-placebo/Pravastatin | Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily |
| FG002 | Lisinopril/Pravastatin | Lisinopril 10mg and Pravastatin 20mg once daily |
| FG003 | L-placebo/P-placebo | Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lisinopril/P-placebo | Lisinopril 10mg and placebo (matched to pravastatin) once daily |
| BG001 | L-placebo/Pravastatin | Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants who stated (by self-report) that they had side effects | Posted | Number | participants | 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lisinopril/P-placebo | Lisinopril 10mg and placebo (matched to pravastatin) once daily |
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Study was small with limited power to detect differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Baker | Minneapolis Medical Foundation | 612-873-2705 | baker459@umn.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Lisinopril | Drug | Participants randomized to take lisinopril (active) or matching placebo pill once daily |
|
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
| change from baseline to 4 months |
| Changes in Small Artery Elasticity | 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. | change from baseline to 4 months |
| Changes hsCRP (C-reactive Protein) | This biomarker represents systemic inflammation within in the body. | change from baseline to 4 months |
| Changes IL-6 (Interleukin-6) | This biomarker represents systemic inflammation within in the body. | change from baseline to 4 months |
| Changes TNFa (Tumor Necrosis Factor Alpha) | This biomarker represents systemic inflammation within in the body. | change from baseline to 4 months |
| BG002 | Lisinopril/Pravastatin | Lisinopril 10mg and Pravastatin 20mg once daily |
| BG003 | L-placebo/P-placebo | Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Lisinopril/Pravastatin | Lisinopril 10mg and Pravastatin 20mg once daily |
| OG003 | L-placebo/P-placebo | Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily |
|
|
| Primary | Number of Participants Who Took >90% of Their Doses (by Pill Count) | 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' | 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 | Posted | Number | participants | 4 months |
|
|
|
| Primary | Change From Baseline to Month 4 in the Framingham Risk Score (FRS) | 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) | 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. | Posted | Median | Inter-Quartile Range | Percent probability of CHD event in 10yr | Change from baseline to 4 months |
|
|
|
| Secondary | Changes in Blood Pressure | Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit) | 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). | Posted | Mean | 95% Confidence Interval | (mmHG) | change from baseline to 4 months |
|
|
|
| Secondary | Changes in Blood Lipids | 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 | 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). | Posted | Mean | 95% Confidence Interval | (mg/dL) | change from baseline to 4 months |
|
|
|
| Secondary | Changes in Small Artery Elasticity | 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. | 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 | Posted | Mean | Standard Error | mL/mmHgx100 | change from baseline to 4 months |
|
|
|
| Secondary | Changes hsCRP (C-reactive Protein) | This biomarker represents systemic inflammation within in the body. | 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 | Posted | Geometric Mean | Standard Error | mcg/mL | change from baseline to 4 months |
|
|
|
| Secondary | Changes IL-6 (Interleukin-6) | This biomarker represents systemic inflammation within in the body. | 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 | Posted | Geometric Mean | Standard Error | pg/mL | change from baseline to 4 months |
|
|
|
| Secondary | Changes TNFa (Tumor Necrosis Factor Alpha) | This biomarker represents systemic inflammation within in the body. | 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 | Posted | Geometric Mean | Standard Error | pg/mL | change from baseline to 4 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | L-placebo/Pravastatin | Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily | 0 | 9 | 0 | 10 |
| EG002 | Lisinopril/Pravastatin | Lisinopril 10mg and Pravastatin 20mg once daily | 0 | 9 | 0 | 10 |
| EG003 | L-placebo/P-placebo | Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily | 0 | 9 | 0 | 10 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|