Cardiovascular Prevention for Persons With HIV

NCT00982189 | Completed Results

• 1 other identifier: PCC-003
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Cardiovascular Disease Risk

Keywords

treatment experienced

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Stated (by Self-report) That They Had Side Effects

  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.

  4 months

• Number of Participants Who Took >90% of Their Doses (by Pill Count)

  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'

  4 months

• Change From Baseline to Month 4 in the Framingham Risk Score (FRS)

  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)

  Change from baseline to 4 months

Secondary Outcomes (6)

• Changes in Blood Pressure

  change from baseline to 4 months

• Changes in Blood Lipids

  change from baseline to 4 months

• Changes in Small Artery Elasticity

  change from baseline to 4 months

• Changes hsCRP (C-reactive Protein)

  change from baseline to 4 months

• Changes IL-6 (Interleukin-6)

  change from baseline to 4 months

Study Arms (4)

Lisinopril

EXPERIMENTAL

Lisinopril 10mg once daily

Drug: Lisinopril

Lisinopril Placebo

PLACEBO COMPARATOR

Placebo pill (matched to lisinopril) once daily

Drug: Lisinopril

Pravastatin

EXPERIMENTAL

Pravastatin 20mg once daily

Drug: Pravastatin

Pravastatin placebo

PLACEBO COMPARATOR

Placebo pill (matched to pravastatin) once daily

Drug: Pravastatin

Interventions

Pravastatin DRUG

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

Pravastatin; Pravastatin placebo

Lisinopril DRUG

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

Lisinopril; Lisinopril Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• American Heart Association: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• 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.

  PMID: 23082133 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Pravastatin; Lisinopril

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study was small with limited power to detect differences.

Results Point of Contact

• Title: Dr. Jason Baker
• Organization: Minneapolis Medical Foundation

baker459@umn.edu

612-873-2705

Study Officials

• Jason Baker, MD

  Hennepin Faculty Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: November 22, 2017
• Results First Posted: April 18, 2012

Record last verified: 2017-10

Locations

US (1)