This trial is active, not recruiting.

Conditions cardiovascular diseases, atherosclerosis, acquired immunodeficiency syndrome, hiv infections
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Start date October 2006
Trial size 1000 participants
Trial identifier NCT00312468, 1334, R01 HL083760-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model defined population
Time perspective longitudinal

Eligibility Criteria

Female participants at least 13 years old.

Inclusion Criteria: - Enrolled in the WIHS study

Additional Information

Official title Mechanisms of Atherosclerosis and CVD in HIV+ Women
Principal investigator Robert C. Kaplan, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).