Cardiovascular Prevention for Persons With HIV

Hennepin Healthcare Research Institute37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

HIV Infection Cardiovascular Disease Risk

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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'

Time frame: 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)

Time frame: Change from baseline to 4 months

Secondary Outcomes

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)