Clinical trial NCT00982189: Cardiovascular Prevention for Persons With HIV
Official title: Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Cardiovascular Disease Risk
Keywords: treatment experienced
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2009-09-23
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Who Stated (by Self-report) That They Had Side Effects
timeFrame: 4 months
measure: Number of Participants Who Took >90% of Their Doses (by Pill Count)
timeFrame: 4 months
measure: Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
timeFrame: Change from baseline to 4 months
Secondary outcomes:
measure: Changes in Blood Pressure
timeFrame: change from baseline to 4 months
measure: Changes in Blood Lipids
timeFrame: change from baseline to 4 months
measure: Changes in Small Artery Elasticity
timeFrame: change from baseline to 4 months
measure: Changes hsCRP (C-reactive Protein)
timeFrame: change from baseline to 4 months
measure: Changes IL-6 (Interleukin-6)
timeFrame: change from baseline to 4 months
measure: Changes TNFa (Tumor Necrosis Factor Alpha)
timeFrame: change from baseline to 4 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Faculty Associates
name: Jason Baker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.