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

This study has been completed.
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: March 1, 2011
Last updated: May 29, 2015
Last verified: May 2015
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.

HIV Infection
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk

Resource links provided by NLM:

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

Primary Outcome Measures:
  • brachial artery flow-mediated dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, PBMCs

Estimated Enrollment: 270
Study Start Date: April 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Treated HIV-infected individuals with an undetectable HIV RNA level (< 75 copies RNA/mL, untreated HIV-infected individuals, and HIV-uninfected individuals.


Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Treated and untreated HIV-infected individuals and HIV-uninfected individuals.

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).
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Please refer to this study by its identifier: NCT01333644

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

Responsible Party: University of California, San Francisco Identifier: NCT01333644     History of Changes
Other Study ID Numbers: HIV FMD AGING 
Study First Received: March 1, 2011
Last Updated: May 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV Infection
Endothelial function
Cardiovascular Disease
Antiretroviral medication
Treatment naive
Treatment experienced

Additional relevant MeSH terms:
Cardiovascular Diseases
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases processed this record on May 24, 2016