Cardiovascular Prevention for Persons With HIV (AHA pilot)
This study has been completed.
Sponsor:
Minneapolis Medical Research Foundation
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00982189
First received: September 22, 2009
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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 | Intervention |
|---|---|
|
HIV Infection Cardiovascular Disease Risk |
Drug: Pravastatin Drug: Lisinopril |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study |
Resource links provided by NLM:
Further study details as provided by Minneapolis Medical Research Foundation:
Primary Outcome Measures:
- Number of Participants Who Stated (by Self-report) That They Had Side Effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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:
- Changes in Blood Pressure [ Time Frame: change from baseline to 4 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 Biomarkers [ Time Frame: change from baseline to 4 months ] [ Designated as safety issue: No ]The biomarkers assessed in this study were soluble proteins measured in blood, or the plasma component of blood. The biomarkers measured represent inflammation and activation of the immune system in the body.
| Enrollment: | 37 |
| Study Start Date: | September 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982189
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982189
Locations
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
Sponsors and Collaborators
Minneapolis Medical Research Foundation
American Heart Association
Investigators
| Principal Investigator: | Jason Baker, MD | Hennepin Faculty Associates |
More Information
No publications provided by Minneapolis Medical Research Foundation
Additional 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 |
| Study First Received: | September 22, 2009 |
| Results First Received: | January 16, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Minneapolis Medical Research Foundation:
|
treatment experienced |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Cardiovascular Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Lisinopril Pravastatin Angiotensin-Converting Enzyme Inhibitors |
Anticholesteremic Agents Antihypertensive Agents Antimetabolites Cardiotonic Agents Cardiovascular Agents Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015