Use of EndoPAT for Measurements of Endothelial Dysfunction in HIV Infected Children and Healthy Controls

March 6, 2015 updated by: Grace McComsey, University Hospitals Cleveland Medical Center
Our objective is to determine whether HIV infected youth have higher level of endothelial dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched healthy controls. The investigators also aim to gather preliminary data on whether endothelial Peripheral Arterial Tonometry (endoPAT) measurements of endothelial dysfunction are independently associated with HIV and antiretroviral factors, and with markers of inflammation and traditional cardiovascular disease risk.

Study Overview

Status

Completed

Conditions

Detailed Description

Study Objectives and Hypothesis Our objective is to determine whether HIV infected youth have higher level of endothelial dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched healthy controls. We also aim to gather preliminary data on whether endoPAT measurements of endothelial dysfunction are independently associated with HIV and antiretroviral factors, and with markers of inflammation and traditional cardiovascular disease risk.

Specific Aim 1:

To compare endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls.

Hypothesis: HIV infected youths will have impaired endothelial function compared to age matched healthy controls.

Specific Aim 2:

To determine risk factors of endothelial dysfunction by evaluating: 1) risk factors specific to HIV such as disease stage, cluster of differentiation 4 (CD4) count, HIV viral load, specific ART regimen, perinatally acquired versus behaviorally acquired infection; 2) markers of cardiovascular disease risk such as smoking, lipid levels, insulin resistance; 3) markers of inflammation and immune activation Hypothesis: Endothelial dysfunction will correlate with advanced HIV disease stage, use of protease inhibitors and worse traditional cardiovascular disease risk factors including lipids, insulin resistance, and smoking.

Specific Aim 3:

To assess whether endothelial function changes over a period of 24 weeks in HIV infected youths and controls.

Hypothesis: Endothelial dysfunction will progress over time in HIV-infected children but not in healthy controls.

Study Design This is a 24-week observational cohort study to gather preliminary data on the prevalence and risk factors for endothelial dysfunction in HIV-infected youths. Children enrolled will be between the ages of 8 and 30 years and either congenitally or behaviorally infected with HIV, on continuous ART for at least 6 months and with HIV-1 RNA <1,000 copies/mL. We will also enroll an age- and gender-matched group of healthy controls. A total of 50 HIV-infected children/young adults and 50 matched controls will be enrolled.

Evaluations will be performed at two time points: baseline and week 24. At both visits, evaluations will be similar. We will collect demographic data and medical history including date of birth, sex, gender, CD4 cell count nadir, past and current ART and non-ART medication history, HIV stage based on the CDC guidelines, HIV diagnosis date and method of HIV acquisition, alcohol, smoking and drug habits, as well as family history of cardiovascular disease or diabetes. We will record clinical measurements including blood pressure, physical examination abnormalities, waist and hip circumferences and tanner stage. Subjects will undergo laboratory measurements of lipids levels and markers of insulin resistance in a fasting state (>8 hrs fast except for water and medications), as well as inflammation and immune activation markers (hsCRP, Interleukin 6 or IL-6, sCD14). HIV RNA and CD4 cell count will be collected from clinical records. Plasma and serum will be stored for possible future measurements of other inflammation and cardiovascular markers. We will perform endothelial function measurements by PAT as recommended by the manufacturer.

Controls will be recruited from the community using Institutional Review Board (IRB)-approved flyers, as uninfected siblings or relatives of the HIV-infected patients, or from physician referrals.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Special Immunology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. HIv positive: subjects seen at the Special Immunology Unit
  2. Controls: HIV-negative controls will be healthy people who are friends or family members of the HIV-infected patients, or employees who are not employed by the principal investigator or the co-investigators or recruited through researchmatch.org

Description

Inclusion Criteria:

  • For HIV+ group:
  • age 8-30 years of age
  • HIV infection
  • On continuous ART for at least 6 months
  • HIV-1 RNA < 1,000 copies/mL performed in the past 5 months

For healthy controls:

  • age and gender matched 1:1 to HIV-positive subjects
  • absence of known HIV or other medical conditions that may affect systemic inflammation
  • Not receiving or prescribed any regular chronic medications.

Exclusion Criteria:

  • - Active illness or regular medication
  • Diabetes
  • Known coronary artery disease
  • Pregnancy and or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HIV positive
people with HIV diagnosis
Control (HIV negative)
people without HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls
Time Frame: one year
Endothelial function will be measured using peripheral arterial tonometry. The device will record finger arterial pulsatile volume changes. The recordings will be performed with the patient in supine position with both hands at the same level. A blood pressure cuff will be placed on the upper arm (non-dominant); the probes will be placed on the finger of each hand (same finger on both hands) and continuing recording of blood volume responses from both hands will be initiated. After a period of stabilization, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will be deflated to induce reactive hyperemia and assess PAT. A reactive hyperemia index will be generated and is the post to pre occlusion PAT signal ratio in the occluded side normalized to the control side and corrected for baseline vascular tone. A normal index is >1.67 and abnormal is ≤ 1.67.
one year
risk factors of endothelial dysfunction
Time Frame: one year
To determine risk factors of endothelial dysfunction by evaluating: 1) risk factors specific to HIV such as disease stage, CD4 count, HIV viral load, specific ART regimen, perinatally acquired versus behaviorally acquired infection; 2) markers of cardiovascular disease risk such as smoking, lipid levels, insulin resistance; 3) markers of inflammation and immune activation
one year
endothelial function changes over a period of 24 weeks in HIV infected youths and controls.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 05-14-22 (Other Identifier: University Hospital IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe