Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

NCT01519141 | Completed

• 2 other identifiers: R01HL0951305R01HL095130
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis

Keywords

Human Immunodeficiency Virus; Atherosclerosis; Inflammation; Endothelial Function; Thrombosis

Outcome Measures

Primary Outcomes (3)

• carotid intima-media thickness

  Increased carotid intima-media thickness (mm)

  2 years

• brachial artery flow-mediated dilatation

  decreased brachial artery flow-mediated dilatation (%)

  2 years

• D-dimer

  Increased D-dimer levels (mcg/mL)

  2 years

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California San Francisco, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Hsue PY, Scherzer R, Hunt PW, Schnell A, Bolger AF, Kalapus SC, Maka K, Martin JN, Ganz P, Deeks SG. Carotid Intima-Media Thickness Progression in HIV-Infected Adults Occurs Preferentially at the Carotid Bifurcation and Is Predicted by Inflammation. J Am Heart Assoc. 2012 Apr;1(2):jah3-e000422. doi: 10.1161/JAHA.111.000422. Epub 2012 Apr 24.

  PMID: 23130122 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Acquired Immunodeficiency Syndrome; Inflammation; Thrombosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• Priscilla Hsue, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 26, 2012
• Study Start: July 1, 2003
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

US (1)