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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01333644

Enrollment

270

Registered

2011-04-12

Start date

2010-04-30

Completion date

2014-12-31

Last updated

2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, HIV Infection, Inflammation

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
brachial artery flow-mediated dilatation	2 years

Countries

United States

Outcome results