HIVNCT02324179
Use of EndoPAT for Measurements of Endothelial Dysfunction in HIV Infected Children and Healthy Controls
An observational study of HIV and Endothelial Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Endothelial Dysfunction
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- - Active illness or regular medication
- Diabetes
- Known coronary artery disease
- Pregnancy and or lactation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV, Endothelial Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | people with HIV diagnosis | |
| Control (HIV negative) | people without HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls
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.
Measured: one year
risk factors of endothelial dysfunction
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
Measured: one year
endothelial function changes over a period of 24 weeks in HIV infected youths and controls.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
- Investigators
- Grace McComsey, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324179
- Sponsor's protocol ID
- 05-14-22
- Other IDs
- 05-14-22
- Status last verified
- Mar 2015
- First submitted
- 28 Aug 2014
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8. doi: 10.1016/s0735-1097(03)00329-2.
PubMed 12767662Escarcega RO, Franco JJ, Mani BC, Vyas A, Tedaldi EM, Bove AA. Cardiovascular disease in patients with chronic human immunodeficiency virus infection. Int J Cardiol. 2014 Jul 15;175(1):1-7. doi: 10.1016/j.ijcard.2014.04.155. Epub 2014 Apr 21.
PubMed 24798779Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Nedeljkovic ZS, Menzoian JO, Vita JA. Predictive value of noninvasively determined endothelial dysfunction for long-term cardiovascular events in patients with peripheral vascular disease. J Am Coll Cardiol. 2003 May 21;41(10):1769-75. doi: 10.1016/s0735-1097(03)00333-4.
PubMed 12767663Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
PubMed 18458169Hamburg NM, Palmisano J, Larson MG, Sullivan LM, Lehman BT, Vasan RS, Levy D, Mitchell GF, Vita JA, Benjamin EJ. Relation of brachial and digital measures of vascular function in the community: the Framingham heart study. Hypertension. 2011 Mar;57(3):390-6. doi: 10.1161/HYPERTENSIONAHA.110.160812. Epub 2011 Jan 24.
PubMed 21263120Hijmering ML, Stroes ES, Pasterkamp G, Sierevogel M, Banga JD, Rabelink TJ. Variability of flow mediated dilation: consequences for clinical application. Atherosclerosis. 2001 Aug;157(2):369-73. doi: 10.1016/s0021-9150(00)00748-6.
PubMed 11472736Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74. doi: 10.1016/S0002-8703(03)00094-2.
PubMed 12851627Moerland M, Kales AJ, Schrier L, van Dongen MG, Bradnock D, Burggraaf J. Evaluation of the EndoPAT as a Tool to Assess Endothelial Function. Int J Vasc Med. 2012;2012:904141. doi: 10.1155/2012/904141. Epub 2012 Feb 14.
PubMed 22500237Poredos P. Endothelial dysfunction in the pathogenesis of atherosclerosis. Int Angiol. 2002 Jun;21(2):109-16.
PubMed 12110769Poredos P, Jezovnik MK. Testing endothelial function and its clinical relevance. J Atheroscler Thromb. 2013;20(1):1-8. doi: 10.5551/jat.14340. Epub 2012 Sep 10.
PubMed 22972428Schnabel RB, Schulz A, Wild PS, Sinning CR, Wilde S, Eleftheriadis M, Herkenhoff S, Zeller T, Lubos E, Lackner KJ, Warnholtz A, Gori T, Blankenberg S, Munzel T. Noninvasive vascular function measurement in the community: cross-sectional relations and comparison of methods. Circ Cardiovasc Imaging. 2011 Jul;4(4):371-80. doi: 10.1161/CIRCIMAGING.110.961557. Epub 2011 May 6.
PubMed 21551420Schnall RP, Shlitner A, Sheffy J, Kedar R, Lavie P. Periodic, profound peripheral vasoconstriction--a new marker of obstructive sleep apnea. Sleep. 1999 Nov 1;22(7):939-46.
PubMed 10566912Selamet Tierney ES, Newburger JW, Gauvreau K, Geva J, Coogan E, Colan SD, de Ferranti SD. Endothelial pulse amplitude testing: feasibility and reproducibility in adolescents. J Pediatr. 2009 Jun;154(6):901-5. doi: 10.1016/j.jpeds.2008.12.028. Epub 2009 Feb 12.
PubMed 19217124Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
PubMed 14522472Xu Y, Arora RC, Hiebert BM, Lerner B, Szwajcer A, McDonald K, Rigatto C, Komenda P, Sood MM, Tangri N. Non-invasive endothelial function testing and the risk of adverse outcomes: a systematic review and meta-analysis. Eur Heart J Cardiovasc Imaging. 2014 Jul;15(7):736-46. doi: 10.1093/ehjci/jet256. Epub 2014 Jan 7.
PubMed 24399339
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of EndoPAT for Measurements of Endothelial Dysfunction in HIV Infected Children and Healthy Controls
- ClinicalTrials.gov ID
- NCT02324179
- Acronym / sponsor ID
- 05-14-22
- Conditions
- HIV, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | –people with HIV diagnosis |
| Control (HIV negative) | – | –people without HIV |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- - Active illness or regular medication
- Diabetes
- Known coronary artery disease
- Pregnancy and or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
endothelial function changes over a period of 24 weeks in HIV infected youths and controls.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Results publication: PubMed 12767662Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8. doi: 10.1016/s0735-1097(03)00329-2.
- Results publication: PubMed 24798779Escarcega RO, Franco JJ, Mani BC, Vyas A, Tedaldi EM, Bove AA. Cardiovascular disease in patients with chronic human immunodeficiency virus infection. Int J Cardiol. 2014 Jul 15;175(1):1-7. doi: 10.1016/j.ijcard.2014.04.155. Epub 2014 Apr 21.
- Results publication: PubMed 12767663Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Nedeljkovic ZS, Menzoian JO, Vita JA. Predictive value of noninvasively determined endothelial dysfunction for long-term cardiovascular events in patients with peripheral vascular disease. J Am Coll Cardiol. 2003 May 21;41(10):1769-75. doi: 10.1016/s0735-1097(03)00333-4.
- Results publication: PubMed 18458169Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
- Results publication: PubMed 21263120Hamburg NM, Palmisano J, Larson MG, Sullivan LM, Lehman BT, Vasan RS, Levy D, Mitchell GF, Vita JA, Benjamin EJ. Relation of brachial and digital measures of vascular function in the community: the Framingham heart study. Hypertension. 2011 Mar;57(3):390-6. doi: 10.1161/HYPERTENSIONAHA.110.160812. Epub 2011 Jan 24.
- Results publication: PubMed 11472736Hijmering ML, Stroes ES, Pasterkamp G, Sierevogel M, Banga JD, Rabelink TJ. Variability of flow mediated dilation: consequences for clinical application. Atherosclerosis. 2001 Aug;157(2):369-73. doi: 10.1016/s0021-9150(00)00748-6.
- Results publication: PubMed 12851627Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74. doi: 10.1016/S0002-8703(03)00094-2.
- Results publication: PubMed 22500237Moerland M, Kales AJ, Schrier L, van Dongen MG, Bradnock D, Burggraaf J. Evaluation of the EndoPAT as a Tool to Assess Endothelial Function. Int J Vasc Med. 2012;2012:904141. doi: 10.1155/2012/904141. Epub 2012 Feb 14.
- Results publication: PubMed 12110769Poredos P. Endothelial dysfunction in the pathogenesis of atherosclerosis. Int Angiol. 2002 Jun;21(2):109-16.
- Results publication: PubMed 22972428Poredos P, Jezovnik MK. Testing endothelial function and its clinical relevance. J Atheroscler Thromb. 2013;20(1):1-8. doi: 10.5551/jat.14340. Epub 2012 Sep 10.
- Results publication: PubMed 21551420Schnabel RB, Schulz A, Wild PS, Sinning CR, Wilde S, Eleftheriadis M, Herkenhoff S, Zeller T, Lubos E, Lackner KJ, Warnholtz A, Gori T, Blankenberg S, Munzel T. Noninvasive vascular function measurement in the community: cross-sectional relations and comparison of methods. Circ Cardiovasc Imaging. 2011 Jul;4(4):371-80. doi: 10.1161/CIRCIMAGING.110.961557. Epub 2011 May 6.
- Results publication: PubMed 10566912Schnall RP, Shlitner A, Sheffy J, Kedar R, Lavie P. Periodic, profound peripheral vasoconstriction--a new marker of obstructive sleep apnea. Sleep. 1999 Nov 1;22(7):939-46.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace McComsey, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Endothelial Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324179, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.