Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312468
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2006-04-06
Brief Title:
Examining the Link Between Heart Disease and HIV Infection in Women
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Mechanisms of Atherosclerosis and CVD in HIV Women
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Womens 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 participants 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
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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL095140 | NIH | None | httpsreporternihgovquickSearch1R01HL095140 |
| 1R01HL083760 | NIH | None | None |
| 1R01HL126543 | NIH | None | None |