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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333644
• Other study ID #: HIV FMD AGING
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: May 29, 2015
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Infection
• HIV Infections
• Inflammation

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brachial artery flow-mediated dilatation		2 years	No