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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
  Purpose

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
Cardiovascular Diseases
Atherosclerosis
Acquired Immunodeficiency Syndrome
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Mechanisms of Atherosclerosis and CVD in HIV+ Women

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Estimated Enrollment: 1000
Study Start Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in the WIHS study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312468

Sponsors and Collaborators
Investigators
Principal Investigator: Robert C. Kaplan, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312468     History of Changes
Other Study ID Numbers: 1334, R01 HL083760-01
Study First Received: April 6, 2006
Last Updated: October 18, 2006
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
AIDS

Additional relevant MeSH terms:
Cardiovascular Diseases
Communicable Diseases
Arterial Occlusive Diseases
Immune System Diseases
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Vascular Diseases
Virus Diseases
Acquired Immunodeficiency Syndrome
Arteriosclerosis
Atherosclerosis
HIV Infections
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 20, 2014