The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
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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 |
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HIV Infection Cardiovascular Disease Inflammation |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk |
Serum, plasma, PBMCs
Estimated Enrollment: | 270 |
Study Start Date: | April 2010 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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.
|
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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).
Contact: Priscilla Hsue, MD | 4152068257 | phsue@medsfgh.ucsf.edu |
Contact: Elaine Nitta, MPH | 4152065145 | nittae@medsfgh.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94110 |
Principal Investigator: | Priscilla Hsue, MD | University of California, San Francisco |
No publications provided
Responsible Party: | Priscilla Hsue, Associate Professor, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01333644 History of Changes |
Other Study ID Numbers: | HIV FMD AGING |
Study First Received: | March 1, 2011 |
Last Updated: | July 9, 2012 |
Health Authority: | United States: Institutional Review Board |
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:
HIV Infections Acquired Immunodeficiency Syndrome Cardiovascular Diseases Inflammation Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2013