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Examining the Link Between Heart Disease and HIV Infection in Women

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00312468
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
1,011
Enrollment
75
Duration (Months)

Study Details

Study Description

Brief Summary

Recent studies have shown that HIV infected individuals have an increased risk of developing heart disease, but the reason for this is not fully understood. This study will examine ultrasound test results of blood vessels and laboratory data of HIV infected and HIV uninfected women to examine the link between heart disease and HIV infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    HIV infected individuals are at increased risk for developing atherosclerosis, which is a build-up of plaque within the arteries and which may lead to various forms of heart disease. It is unknown, however, why individuals with HIV are more susceptible to heart disease compared to others. Atherosclerosis may develop more rapidly due to HIV infection, the use of antiretroviral medications, or a combination of the two. HIV lipodystrophy syndrome, in which body fat distribution is altered, may also be a risk factor. If heart disease is not properly treated, individuals place themselves at risk for heart attacks, strokes, or organ failure. In previous studies involving HIV and heart disease, women have been under-represented. This study will examine a group of women participating in the Women's Interagency HIV Study (WIHS), which is examining the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. By using ultrasound imaging, the progression of subclinical atherosclerosis will be assessed. WIHS study data will then be used to examine possible relationships between atherosclerosis and factors associated with HIV infection in women. The results of this study will have major implications for the development of strategies to predict, prevent, or reverse atherosclerosis and heart disease in HIV infected individuals.

    This 4-year study will enroll 750 HIV infected women and 250 HIV uninfected women who are participating in the WIHS study. Participants will undergo an initial ultrasound imaging of the neck to measure the size and thickness of the arteries. They will return for a repeat ultrasound at Years 2, 3, and 4 to assess any progression of atherosclerosis. Data from the participants' biannual WIHS study visits, including HIV medication usage, viral load and CD4 test results, and occurrence of AIDS and other illnesses, will be reviewed. Results of participant's inflammation marker tests, which may indicate the presence of atherosclerosis, including white blood cell count, C-reactive protein, E-selectin, and intercellular adhesion molecule 1, will also be reviewed.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1011 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mechanisms of Atherosclerosis and CVD in HIV+ Women
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 31, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Women enrolled in the WIHS HIV cohort study

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Albert Einstein College of Medicine
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • Principal Investigator: Robert C. Kaplan, PhD, Albert Einstein College of Medicine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Robert Kaplan, Professor of Epidemiology, Albert Einstein College of Medicine
      ClinicalTrials.gov Identifier:
      NCT00312468
      Other Study ID Numbers:
      • 1334
      • 1R01HL083760
      • 1R01HL126543
      • 1R01HL095140
      First Posted:
      Apr 10, 2006
      Last Update Posted:
      Jul 13, 2018
      Last Verified:
      Jul 1, 2018
      Keywords provided by Robert Kaplan, Professor of Epidemiology, Albert Einstein College of Medicine
      AIDS
      Additional relevant MeSH terms:
      Infections
      HIV Infections
      Acquired Immunodeficiency Syndrome
      Cardiovascular Diseases
      Atherosclerosis
      Immunologic Deficiency Syndromes

      Study Results

      No Results Posted as of Jul 13, 2018