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
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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 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 |

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
|
- 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.
- 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'
- 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)
- 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)
- 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
- 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.
- Changes hsCRP (C-reactive Protein) [ Time Frame: change from baseline to 4 months ]This biomarker represents systemic inflammation within in the body.
- Changes IL-6 (Interleukin-6) [ Time Frame: change from baseline to 4 months ]This biomarker represents systemic inflammation within in the body.
- Changes TNFa (Tumor Necrosis Factor Alpha) [ Time Frame: change from baseline to 4 months ]This biomarker represents systemic inflammation within in the body.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Minnesota | |
Hennepin County Medical Center | |
Minneapolis, Minnesota, United States, 55415 |
Principal Investigator: | Jason Baker, MD | Hennepin Faculty Associates |
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 |