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Cardiovascular Prevention for Persons With HIV

Primary Purpose

HIV Infection, Cardiovascular Disease Risk

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pravastatin
Lisinopril
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring treatment experienced

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
  • Age ≥40
  • Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy

Exclusion Criteria:

  • Known cardiovascular disease or Framingham risk score (FRS) ≥20%
  • Blood pressure ≥140/90
  • LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%)
  • Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
  • Cirrhosis or plasma ALT/AST levels >2x upper limit of normal
  • Chronic kidney disease and a creatinine >2.0mg/dL
  • Triglycerides >500mg/dL

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Lisinopril

Lisinopril Placebo

Pravastatin

Pravastatin placebo

Arm Description

Lisinopril 10mg once daily

Placebo pill (matched to lisinopril) once daily

Pravastatin 20mg once daily

Placebo pill (matched to pravastatin) once daily

Outcomes

Primary Outcome Measures

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 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'
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)

Secondary Outcome Measures

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)
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
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.
Changes hsCRP (C-reactive Protein)
This biomarker represents systemic inflammation within in the body.
Changes IL-6 (Interleukin-6)
This biomarker represents systemic inflammation within in the body.
Changes TNFa (Tumor Necrosis Factor Alpha)
This biomarker represents systemic inflammation within in the body.

Full Information

First Posted
September 22, 2009
Last Updated
October 19, 2017
Sponsor
Hennepin Healthcare Research Institute
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00982189
Brief Title
Cardiovascular Prevention for Persons With HIV
Official Title
Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Cardiovascular Disease Risk
Keywords
treatment experienced

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisinopril
Arm Type
Experimental
Arm Description
Lisinopril 10mg once daily
Arm Title
Lisinopril Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill (matched to lisinopril) once daily
Arm Title
Pravastatin
Arm Type
Experimental
Arm Description
Pravastatin 20mg once daily
Arm Title
Pravastatin placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill (matched to pravastatin) once daily
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
Participants randomized to take pravastatin (active) or matching placebo pill once daily
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
Participants randomized to take lisinopril (active) or matching placebo pill once daily
Primary Outcome Measure Information:
Title
Number of Participants Who Stated (by Self-report) That They Had Side Effects
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
Title
Number of Participants Who Took >90% of Their Doses (by Pill Count)
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
Title
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
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
Secondary Outcome Measure Information:
Title
Changes in Blood Pressure
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
Title
Changes in Blood Lipids
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
Title
Changes in Small Artery Elasticity
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
Title
Changes hsCRP (C-reactive Protein)
Description
This biomarker represents systemic inflammation within in the body.
Time Frame
change from baseline to 4 months
Title
Changes IL-6 (Interleukin-6)
Description
This biomarker represents systemic inflammation within in the body.
Time Frame
change from baseline to 4 months
Title
Changes TNFa (Tumor Necrosis Factor Alpha)
Description
This biomarker represents systemic inflammation within in the body.
Time Frame
change from baseline to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV Infection with viral load 'undetectable' while taking antiretroviral therapy Age ≥40 Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy Exclusion Criteria: Known cardiovascular disease or Framingham risk score (FRS) ≥20% Blood pressure ≥140/90 LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%) Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication Cirrhosis or plasma ALT/AST levels >2x upper limit of normal Chronic kidney disease and a creatinine >2.0mg/dL Triglycerides >500mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Baker, MD
Organizational Affiliation
Hennepin Faculty Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23082133
Citation
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.
Results Reference
derived

Learn more about this trial

Cardiovascular Prevention for Persons With HIV

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