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Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01519141
First received: January 12, 2012
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years.

Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry.

To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia.

The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunologic and Inflammatory Factors and Cardiovascular Risk in Patients With HIV Infection or Autoimmune Diseases

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • carotid intima-media thickness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Increased carotid intima-media thickness (mm)

  • brachial artery flow-mediated dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    decreased brachial artery flow-mediated dilatation (%)

  • D-dimer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Increased D-dimer levels (mcg/mL)


Estimated Enrollment: 400
Study Start Date: July 2003
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-negative controls
HIV-negative individuals
HIV-infected patients
HIV-infected patients who are on a stable antiretroviral drug regimen for at least a year; all plasma HIV RNA levels within the past year must be below conventional levels of detection (< 50 copies RNA/mL).

Detailed Description:

This proposal is currently approved by CHR (#H9577-18534-03C, exp date 3/26/04); the purpose of this new application is to split the currently approved protocol into a separate protocol with a separate PI. Data collected and patients seen under the previously approved protocol will be carried over into this new separate protocol. This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients, and individuals with autoimmune diseases. We plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. In addition, patients will undergo ct scan for coronary calcium and single slice abdominal ct scan to assess visceral fat. We will also measure lipid and lipoprotein levels, inflammatory markers, markers of CMV infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T cells,T cell turnover, proportions of T cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviours. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. In patients with detectable calcium on CT scan, they will be given the option of obtaining CT angiography. Patients will also undergo testing for peripheral arterial disease using ankle brachial index testing and exercise treadmill testing.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

325 well-characterized HIV-infected individuals and 75 HIV-uninfected individuals.

Criteria

Inclusion Criteria:

  • Stable antiretroviral therapy for at least 12 months, and have no immediate plans to alter therapy.
  • All plasma HIV RNA levels within the past year must be below conventional levels of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 1000 copies will be allowed if they were preceded and followed by undetectable viral load determinations.
  • Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment
  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: NCT01519141

Contacts
Contact: Priscilla Hsue, MD 4152068257 phsue@medsfgh.ucsf.edu
Contact: Courtney Carroll, MA 4152065145 carrollc@sfgh.ucsf.edu

Locations
United States, California
University of California San Francisco, San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Priscilla Hsue, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Priscilla Hsue, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Priscilla Hsue, Clinician-Scientist, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01519141     History of Changes
Other Study ID Numbers: R01HL095130, 5R01HL095130
Study First Received: January 12, 2012
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Human Immunodeficiency Virus
Atherosclerosis
Inflammation
Endothelial Function
Thrombosis

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

ClinicalTrials.gov processed this record on November 25, 2014