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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 Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV Infection Cardiovascular Disease Risk Drug: Pravastatin Drug: Lisinopril Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lisinopril
Lisinopril 10mg once daily
 Drug: Lisinopril
Participants randomized to take lisinopril (active) or matching placebo pill once daily
Placebo Comparator: Lisinopril Placebo
Placebo pill (matched to lisinopril) once daily
 Drug: Lisinopril
Participants randomized to take lisinopril (active) or matching placebo pill once daily
Experimental: Pravastatin
Pravastatin 20mg once daily
 Drug: Pravastatin
Participants randomized to take pravastatin (active) or matching placebo pill once daily
Placebo Comparator: Pravastatin placebo
Placebo pill (matched to pravastatin) once daily
 Drug: Pravastatin
Participants randomized to take pravastatin (active) or matching placebo pill once daily


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

  2. Number of Participants Who Took >90% of Their Doses (by Pill Count) [ Time Frame: 4 months ]
    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'

  3. Change From Baseline to Month 4 in the Framingham Risk Score (FRS) [ Time Frame: Change from baseline to 4 months ]
    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 :
  1. Changes in Blood Pressure [ Time Frame: change from baseline to 4 months ]
    Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)

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

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

  4. Changes hsCRP (C-reactive Protein) [ Time Frame: change from baseline to 4 months ]
    This biomarker represents systemic inflammation within in the body.

  5. Changes IL-6 (Interleukin-6) [ Time Frame: change from baseline to 4 months ]
    This biomarker represents systemic inflammation within in the body.

  6. Changes TNFa (Tumor Necrosis Factor Alpha) [ Time Frame: change from baseline to 4 months ]
    This biomarker represents systemic inflammation within in the body.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982189


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
American Heart Association
Investigators
Principal Investigator: Jason Baker, MD Hennepin Faculty Associates
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Posted: September 23, 2009    Key Record Dates
Results First Posted: April 18, 2012
Last Update Posted: November 22, 2017
Last Verified: October 2017

Keywords provided by Minneapolis Medical Research Foundation:
treatment experienced

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Pravastatin
 Lisinopril
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs