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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 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: January 15, 2014
Last verified: January 2014
  Purpose

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
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

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

  Eligibility

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.

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
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

Contacts
Contact: Priscilla Hsue, MD 4152068257 phsue@medsfgh.ucsf.edu
Contact: Courtney Carroll, MA 4152065145 carrollc@sfgh.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
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

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: January 15, 2014
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:
Inflammation
Cardiovascular Diseases
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Pathologic Processes
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

ClinicalTrials.gov processed this record on September 16, 2014