Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People

NCT00919724 | Completed Results DMC

• 3 other identifiers: 661R01HL095149HL095149
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The blood vessels that carry blood from the heart to the rest of the body are normally capable of relaxing and constricting when needed to provide more or less blood to the body. The inability of blood vessels to relax and widen may increase the risk of heart disease and stroke. One potential cause of this inability is inflammation. Because HIV infection is associated with inflammation, it is possible that the blood vessels in people infected with HIV may not relax properly. The purpose of this study is to determine whether people infected with HIV have worse blood vessel function than people without HIV infection.

Conditions

HIV Infection

Keywords

AIDS; Endothelial Function; Inflammation; Immune Activation; treatment naive

Outcome Measures

Primary Outcomes (1)

• Endothelial Function (Brachial Artery Reactivity)

  The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.

  Single measurement

Study Arms (2)

HIV-Infected

HIV-infected participants who are not currently receiving antiretroviral medications

HIV-Uninfected

HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants

Eligibility Criteria

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

Study Population

HIV-infected people will be recruited from infectious diseases outpatient clinics of Wishard Hospital and Indiana University Hospital. They will be enrolled in one of two other HIV trials. HIV-uninfected people will be recruited from the Indianapolis general population.

You may qualify if:

• Positive HIV enzyme-linked immunosorbent assay (ELISA) test with confirmatory Western Blot
• Not currently receiving antiretroviral therapy
• Negative HIV ELISA test at screening
• Within 10 years of age of the matched HIV-infected participant
• Same sex and current smoking status as the matched HIV-infected participant
• Height within 4 inches of the matched HIV-infected participant

You may not qualify if:

• Inability to complete written informed consent
• Incarceration at the time of screening or main study visit
• Diagnosed vascular disease (e.g., history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
• History of bleeding diathesis, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
• Known or suspected cancer requiring systemic treatment within 6 months of screening
• History of migraine headaches
• History of Raynaud's phenomenon
• History of cardiac arrhythmias or cardiomyopathy
• Known allergy or intolerance to nitroglycerin
• History of carotid bruits
• Creatinine clearance less than 50mL/min, using a serum creatinine level measured at screening
• Hemoglobin level greater than 9.0g/dL at screening
• Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) at screening
• Total bilirubin greater than 2.5 times ULN at screening
• Fever, defined as a temperature greater than 38.0 C within 48 hours prior to screening

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Infectious Diseases Research Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, urine

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; 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; Slow Virus Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Samir K. Gupta, MD, MS
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

317-274-7926

Study Officials

• Samir K. Gupta, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 15, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-07

Locations

US (1)