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OpenTrials
Completed

NCT Number: NCT01333644

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. brachial artery flow-mediated dilatation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2011
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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