Cardiovascular Prevention for Persons With HIV

Condition(s) targeted: HIV Infection; Cardiovascular Disease Risk

Intervention: Pravastatin (Drug); Lisinopril (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Minneapolis Medical Research Foundation

Official(s) and/or principal investigator(s):
Jason Baker, MD, Principal Investigator, Affiliation: Hennepin Faculty Associates

Overall contact:
Bette Bordenave, RN, Phone: 612-873-2297

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.

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

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Primary outcome:

Medication Tolerability and Safety

Medication Adherence

Change in Framingham Risk Score

Secondary outcome:

Changes in Blood Pressure

Changes in Blood Lipids

Changes in artery elasticity

Changes in biomarkers

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Bette Bordenave, RN, Phone: 612-873-2297

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

Starting date: September 2009
Ending date: April 2011
Last updated: October 16, 2009