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The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01333644
First received: March 1, 2011
Last updated: October 21, 2014
Last verified: October 2014

March 1, 2011
October 21, 2014
April 2010
December 2014   (final data collection date for primary outcome measure)
brachial artery flow-mediated dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01333644 on ClinicalTrials.gov Archive Site
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The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk

It is the central hypothesis of the investigators study that HIV disease is a pro-inflammatory condition, and that years of inflammation result in premature "aging' of the immune system ("immunosenescence"). Just as these changes are thought be causally associated with heart disease in the very old,the investigators postulate that these changes will be associated with early heart disease in the untreated and perhaps treated HIV disease. To address this hypothesis, the investigators will measure immunosenescence in a large cohort of patients who span the entire disease process.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Serum, plasma, PBMCs

Non-Probability Sample

Treated and untreated HIV-infected individuals and HIV-uninfected individuals.

  • HIV Infection
  • Cardiovascular Disease
  • Inflammation
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HIV-Infection
Treated HIV-infected individuals with an undetectable HIV RNA level (< 75 copies RNA/mL, untreated HIV-infected individuals, and HIV-uninfected individuals.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV controllers: positive for HIV by standard antibody serological determinations with undetectable HIV RNA level (< 75 copies RNA/mL) in absence of therapy
  • HIV non-controllers: detectable HIV RNA levels in absence of therapy
  • Highly active anti-retroviral therapy responders (HAART responders): on combination antiretroviral therapy with undetectable HIV RNA levels.
  • HIV-seronegative participants will also be studied.

Exclusion Criteria:

  • Treated individuals that changed antiretroviral regimen within 12 weeks prior to study enrollment.
  • Individuals who have started or stopped antihypertensive medication or lipid lowering medication or changed doses of these drugs within 12 weeks of the study will be excluded.
  • As nitroglycerin is administered to assess endothelium-independent vasodilation, we also plan to exclude patients who have taken sildenafil, vardenafil, or tadalafil within 72 hours of the endothelial function study, or who are hypotensive (systolic BP <100).
Both
40 Years to 80 Years
Yes
Contact: Priscilla Hsue, MD 4152068257 phsue@medsfgh.ucsf.edu
Contact: Courtney Carroll, MA 4152065145 carrollc@sfgh.ucsf.edu
United States
 
NCT01333644
HIV FMD AGING
Yes
Priscilla Hsue, University of California, San Francisco
University of California, San Francisco
GlaxoSmithKline
Principal Investigator: Priscilla Hsue, MD University of California, San Francisco
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP