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Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00889577
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary purpose of this study is to evaluate the association between nonalcoholic fatty liver disease (NAFLD) by computed tomography (CT) scan and coronary artery disease (CAD) measured by the calcium (CAC) score among HIV-infected persons.

Condition or disease
HIV Infections Coronary Artery Disease Non-Alcoholic Fatty Liver Disease

Study Design

Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
Study Start Date : December 2008
Primary Completion Date : March 2010
Study Completion Date : December 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Coronary artery disease (CAD) measured by the CAC score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To determine the prevalence of coronary artery disease as determined by computed tomography (CT) of the coronary arteries among HIV patients, and to compare it to data from the general population using normative data from recent publications [ Time Frame: 1 year ]
  2. To evaluate predictors for coronary artery disease including demographics, concurrent conditions (e.g., diabetes, hyperlipidemia, tobacco use), and HIV factors such as ARV duration, HIV duration, and lipodystrophy [ Time Frame: 1 year ]
  3. To investigate the relationship between inflammatory markers (CRP, ESR), d-dimer, adiponectin levels, future inflammatory markers, and genetic polymorphisms with the presence of coronary disease and NAFLD [ Time Frame: 1 year ]
  4. To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease [ Time Frame: 1 year ]
  5. To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels [ Time Frame: 1 year ]
  6. To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons [ Time Frame: 1 year ]
  7. To describe the outcome of a positive CAC score in terms of follow-up test/procedure results to help describe the clinical significance of elevated scores. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood samples will be obtained

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV positive patients who had participated in our previous Liver Study at NMCSD will be given the opportunity to participate in this study, as well as HIV patients who did not participate in the Liver Study.

Inclusion Criteria:

  • HIV patients who participated in our previous Liver Study, conducted at NMCSD, and HIV patients who did not participate in the Liver Study.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding will be excluded.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889577

United States, California
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
More Information

Responsible Party: Dr. Nancy Crum-Cianflone, Department Head, US Department of Defense Center for Deployment Health Research, Naval Health Research Center
ClinicalTrials.gov Identifier: NCT00889577     History of Changes
Other Study ID Numbers: IDCRP-018
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
HIV Infections
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases