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Examining the Link Between Heart Disease and HIV Infection in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312468
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : July 13, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Kaplan, Albert Einstein College of Medicine

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
Cardiovascular Diseases Atherosclerosis Acquired Immunodeficiency Syndrome HIV Infections

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.

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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 : October 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women enrolled in the WIHS HIV cohort study

Inclusion Criteria:

  • Women enrolled in the WIHS HIV cohort study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312468

Sponsors and Collaborators
Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Robert C. Kaplan, PhD Albert Einstein College of Medicine

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Responsible Party: Robert Kaplan, Professor of Epidemiology, Albert Einstein College of Medicine Identifier: NCT00312468     History of Changes
Other Study ID Numbers: 1334
1R01HL083760 ( U.S. NIH Grant/Contract )
1R01HL126543 ( U.S. NIH Grant/Contract )
1R01HL095140 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by Robert Kaplan, Albert Einstein College of Medicine:
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Arterial Occlusive Diseases
Vascular Diseases