The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Verified October 2014 by University of California, San Francisco
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
First received: March 1, 2011
Last updated: October 21, 2014
Last verified: October 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
- brachial artery flow-mediated dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated 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:
|Accepts Healthy Volunteers:
Treated and untreated HIV-infected individuals and HIV-uninfected individuals.
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333644
|University of California, San Francisco
|San Francisco, California, United States, 94110 |
University of California, San Francisco
||Priscilla Hsue, MD
||University of California, San Francisco
No publications provided
||Priscilla Hsue, Associate Professor, University of California, San Francisco
History of Changes
|Other Study ID Numbers:
||HIV FMD AGING
|Study First Received:
||March 1, 2011
||October 21, 2014
||United States: Institutional Review Board
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases