Cardiovascular Prevention for Persons With HIV (AHA pilot)

This study has been completed.
Sponsor:
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

September 22, 2009
October 10, 2012
September 2009
December 2010   (final data collection date for primary outcome measure)
  • 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)
  • 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 ]
Complete list of historical versions of study NCT00982189 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Cardiovascular Prevention for Persons With HIV
Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • HIV Infection
  • Cardiovascular Disease Risk
  • Drug: Pravastatin
    Participants randomized to take pravastatin (active) or matching placebo pill once daily
  • Drug: Lisinopril
    Participants randomized to take lisinopril (active) or matching placebo pill once daily
  • Experimental: Lisinopril
    Lisinopril 10mg once daily
    Intervention: Drug: Lisinopril
  • Placebo Comparator: Lisinopril Placebo
    Placebo pill (matched to lisinopril) once daily
    Intervention: Drug: Lisinopril
  • Experimental: Pravastatin
    Pravastatin 20mg once daily
    Intervention: Drug: Pravastatin
  • Placebo Comparator: Pravastatin placebo
    Placebo pill (matched to pravastatin) once daily
    Intervention: Drug: Pravastatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00982189
PCC-003
No
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
American Heart Association
Principal Investigator: Jason Baker, MD Hennepin Faculty Associates
Minneapolis Medical Research Foundation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP