HIV Infections Clinical Trial
Official title:
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.
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