Cardiovascular Prevention for Persons With HIV

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982189
• Other study ID #: PCC-003
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: October 19, 2017
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2017
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiovascular Disease Risk
• Cardiovascular Diseases
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• Pravastatin
Participants randomized to take pravastatin (active) or matching placebo pill once daily
• Lisinopril
Participants randomized to take lisinopril (active) or matching placebo pill once daily

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Primary	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'	4 months
Primary	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)	Change from baseline to 4 months
Secondary	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)	change from baseline to 4 months
Secondary	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	change from baseline to 4 months
Secondary	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.	change from baseline to 4 months
Secondary	Changes hsCRP (C-reactive Protein)	This biomarker represents systemic inflammation within in the body.	change from baseline to 4 months
Secondary	Changes IL-6 (Interleukin-6)	This biomarker represents systemic inflammation within in the body.	change from baseline to 4 months
Secondary	Changes TNFa (Tumor Necrosis Factor Alpha)	This biomarker represents systemic inflammation within in the body.	change from baseline to 4 months