Cardiovascular Prevention for Persons With HIV - Full Text View

Sponsor:	Minneapolis Medical Research Foundation
Collaborator:	American Heart Association
Information provided by:	Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00982189

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:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Pravastatin Pravastatin sodium Lisinopril

U.S. FDA Resources

Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:

Medication Tolerability and Safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Medication Adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change in Framingham Risk Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Changes in Blood Lipids [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Changes in artery elasticity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Changes in biomarkers [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lisinopril: Experimental Lisinopril 10mg once daily	Drug: Lisinopril Participants randomized to take lisinopril (active) or matching placebo pill once daily
Lisinopril Placebo: Placebo Comparator Placebo pill (matched to lisinopril) once daily	Drug: Lisinopril Participants randomized to take lisinopril (active) or matching placebo pill once daily
Pravastatin: Experimental Pravastatin 20mg once daily	Drug: Pravastatin Participants randomized to take pravastatin (active) or matching placebo pill once daily
Pravastatin placebo: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982189

Contacts

Contact: Bette Bordenave, RN

612-873-2297

Locations

United States, Minnesota
Hennepin County Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55415
Principal Investigator: Jason Baker, MD, MS

Sponsors and Collaborators

Minneapolis Medical Research Foundation

American Heart Association

Investigators

Principal Investigator:

Jason Baker, MD

Hennepin Faculty Associates

More Information

No publications provided

Responsible Party:	MMRF ( Jason Baker )
Study ID Numbers:	PCC-003
Study First Received:	September 22, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00982189 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:

treatment experienced

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Infection
Pravastatin
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Retroviridae Infections
RNA Virus Infections
Immune System Diseases

Antilipemic Agents
Acquired Immunodeficiency Syndrome
Lisinopril
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Protective Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on February 08, 2010