Examining the Link Between Heart Disease and HIV Infection in Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00312468
First received: April 6, 2006
Last updated: October 18, 2006
Last verified: October 2006

April 6, 2006
October 18, 2006
October 2006
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Complete list of historical versions of study NCT00312468 on ClinicalTrials.gov Archive Site
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Examining the Link Between Heart Disease and HIV Infection in Women
Mechanisms of Atherosclerosis and CVD in HIV+ Women

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Cardiovascular Diseases
  • Atherosclerosis
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
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Inclusion Criteria:

  • Enrolled in the WIHS study
Female
13 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00312468
1334, R01 HL083760-01
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National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Robert C. Kaplan, PhD Albert Einstein College of Medicine of Yeshiva University
National Heart, Lung, and Blood Institute (NHLBI)
October 2006

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