Cardiovascular Prevention for Persons With HIV

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lisinopril Placebo	Lisinopril	Placebo pill (matched to lisinopril) once daily
Lisinopril	Lisinopril	Lisinopril 10mg once daily
Pravastatin placebo	Pravastatin	Placebo pill (matched to pravastatin) once daily
Pravastatin	Pravastatin	Pravastatin 20mg once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Stated (by Self-report) That They Had Side Effects	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.
Number of Participants Who Took >90% of Their Doses (by Pill Count)	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'
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)	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

Name	Time	Method
Changes TNFa (Tumor Necrosis Factor Alpha)	change from baseline to 4 months	This biomarker represents systemic inflammation within in the body.
Changes in Small Artery Elasticity	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.
Changes in Blood Pressure	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)
Changes in Blood Lipids	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
Changes hsCRP (C-reactive Protein)	change from baseline to 4 months	This biomarker represents systemic inflammation within in the body.
Changes IL-6 (Interleukin-6)	change from baseline to 4 months	This biomarker represents systemic inflammation within in the body.