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Cardiovascular Prevention for Persons With HIV

NCT ID: NCT00982189

Last Updated: 2017-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection Cardiovascular Disease Risk

Keywords

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treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lisinopril

Lisinopril 10mg once daily

Group Type EXPERIMENTAL

Lisinopril

Intervention Type DRUG

Participants randomized to take lisinopril (active) or matching placebo pill once daily

Lisinopril Placebo

Placebo pill (matched to lisinopril) once daily

Group Type PLACEBO_COMPARATOR

Lisinopril

Intervention Type DRUG

Participants randomized to take lisinopril (active) or matching placebo pill once daily

Pravastatin

Pravastatin 20mg once daily

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

Participants randomized to take pravastatin (active) or matching placebo pill once daily

Pravastatin placebo

Placebo pill (matched to pravastatin) once daily

Group Type PLACEBO_COMPARATOR

Pravastatin

Intervention Type DRUG

Participants randomized to take pravastatin (active) or matching placebo pill once daily

Interventions

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Pravastatin

Participants randomized to take pravastatin (active) or matching placebo pill once daily

Intervention Type DRUG

Lisinopril

Participants randomized to take lisinopril (active) or matching placebo pill once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Faculty Associates

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Baker JV, Huppler Hullsiek K, Prosser R, Duprez D, Grimm R, Tracy RP, Rhame F, Henry K, Neaton JD. Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial. PLoS One. 2012;7(10):e46894. doi: 10.1371/journal.pone.0046894. Epub 2012 Oct 17.

Reference Type DERIVED
PMID: 23082133 (View on PubMed)

Other Identifiers

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PCC-003

Identifier Type: -

Identifier Source: org_study_id