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

NCT01333644 | Completed DMC

• 1 other identifier: HIV FMD AGING
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Cardiovascular Disease; Inflammation

Keywords

HIV Infection; Endothelial function; Cardiovascular Disease; Inflammation; Antiretroviral medication; Treatment naive; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• brachial artery flow-mediated dilatation

  2 years

Study Arms (1)

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 Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treated and untreated HIV-infected individuals and HIV-uninfected individuals.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, PBMCs

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Priscilla Hsue, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (1)