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Completed

NCT Number: NCT00982189

Cardiovascular Prevention for Persons With HIV

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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Key information

Conditions

HIV Infection Blood-Borne Infections Cardiovascular Disease Risk Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pravastatin

Drug

Participants randomized to take pravastatin (active) or matching placebo pill once daily

Lisinopril

Drug

Participants randomized to take lisinopril (active) or matching placebo pill once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 23, 2009
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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