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

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ClinicalTrials.gov Identifier: NCT01333644
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
HIV Infection Cardiovascular Disease Inflammation

Study Design

Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Study Start Date : April 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HIV-Infection
Treated HIV-infected individuals with an undetectable HIV RNA level (< 75 copies RNA/mL, untreated HIV-infected individuals, and HIV-uninfected individuals.


Outcome Measures

Primary Outcome Measures :
  1. brachial artery flow-mediated dilatation [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, PBMCs

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Treated and untreated HIV-infected individuals and HIV-uninfected individuals.
Criteria

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).
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): NCT01333644


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01333644     History of Changes
Other Study ID Numbers: HIV FMD AGING
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Inflammation
HIV Infections
Cardiovascular Diseases
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases