Virus-HIVNCT02898896
Coronary Artery Disease (CAD) in Suppressed HIV-infected
A study testing blood test in people with Virus-HIV, run by University Hospital, Montpellier at 1 site in France.
Trial summary
HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation Read more about this study
- Who is it for?
- Ages 48 to 100 years
- Conditions the study is for
- Virus-HIV
- What is being tested?
- blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 5 Jan 2018
- Phase
- Interventional
- 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 48 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART HIV-RNA < 50 copies >= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months
Who cannot join
- Previous CV event (MI, stroke, unstable angina, CABG) Atrial fibrillation Chronic kidney disease [eGFR < 60ml/min MDRD or CKD-Epi) Unstable liver disease History of IV contrast allergy Chronic inflammatory disorders apart from HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asymptomatic Obstructive Coronary Artery Disease (CAD) in Suppressed HIV-infected Patients ≥ 45 Years and 2 or More CV Risk Factors. Associations With Persistent Immune Activation and Microbial Translocation
HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation
Read the detailed description
A hallmark of HIV infection is a state of global immune activation that is only partially restored under highly active antiretroviral therapy. Apart from immune deficiency and impaired immune restoration, this chronic immune activation may result via various mechanisms in non-AIDS linked morbidities such as atherosclerosis. Coronary artery disease (CAD), especially myocardial infarction (MI), is the leading cause of death in Europe [Eurostat 2013]. Cardiovascular deaths are responsible for 8% of deaths among HIV-infected patients in France and for 15% of deaths among HIV-infected patients in US [Lewden C JAIDS 08, Palella FJ JAIDS 06]. Multiple cohort studies have shown that HIV-infected patients are at a higher risk of myocardial infarction than the general population [Triant VA J Clin Endocrinol 07, Freiberg MS JAMA Intern Med 13] and there is some evidence that HIV-infected patients have a 38% greater risk of mortality from MI than controls [Pearce D AM J Cardiol 12].
Several tools for cardiovascular risk stratification are available but current risk scores seem to underestimate this risk in HIV-infected patients. Indeed, a significant proportion of cardiovascular events occur in subjects with none or few risk factors. A European study comparing first episode of MI among HIV-infected patients with uninfected controls showed that 40% had none or only one traditional cardiovascular risk factor [Boccara F Eur Heart J 11]. Another study in general population demonstrates that almost 50% of patients with a MI had no previous history of coronary symptoms [Tunstall-Pedoe H Circulation 96].
The true prevalence of CAD in asymptomatic HIV-infected patients is unknown. Older studies performed in tissue samples from deceased patients demonstrated 3-times greater odds of having obstructive CAD in HIV-infected patients compared with non-infected controls after controlling for age and sex [Micheletti RG Cardiovasc Pathol 09]. A recent meta-analysis shows that the prevalence of coronary stenosis and calcified coronary plaques is similar in comparison with non-HIV age and sex-matched controls but HIV-infected patients have a 3-fold higher prevalence of non-calcified coronary plaques [D'Ascenzo Atherosclerosis 15].
CAD severity detected by coronary computed tomographic angiography (CCTA) is associated with cardiac death or MI and all-cause mortality [Habib F Int J Cardiol 12]. 64 slice or greater CCTA is reported to have a sensitivity of 93 to 97% and specificity of 80 to 90% compared to standard coronary angiography [Fihn SD J Am Coll Cardiol 12]. There is a high correlation between CCTA and invasive coronary angiography in the determination of CAD extent and severity [Miller JM N Engl J Med 08].
Whether routine CCTA screening in high-risk populations can effect changes in treatment (such as pre-emptive coronary revascularization or more aggressive medical therapy) remains unproven. The 2013 AHA guidelines about stable ischemic heart disease states that either stress test or anatomic imaging in higher-risk individuals may be appropriate [J Am Coll Cardiol 14].
Few studies using CCTA have been performed in HIV-infected patients and none of these have been done in intermediate-high risk populations. Most of theses studies have shown an increased prevalence of non-calcified plaques in HIV-infected men (59% vs. 34%) compared with controls non infected with similar CVRF [Lo J AIDS 10, Post W Ann Intern Med 14]. There is some inconsistent data regarding clinical variables associated with coronary stenosis. Meanwhile CD4 nadir, use or ART for more than 10 years and detectable viral load were independently associated with coronary stenosis > 50% in the MACS cohort study [Post W Ann Intern Med 14], another study among African-Americans with HIV only cardiovascular risk factors and cocaine use were associated with coronary stenosis [Lai S Clin Infec Dis 08] Although the epidemiology and pathogenesis of HIV associated cardiovascular disease are complex and controversial we know that the risk of cardiovascular events is higher in untreated than treated HIV infection, probably because inflammation is increased in untreated infection. Recent data have raised interest in the role of Monocytes/macrophages in HIV-associated cardiovascular disease. Increased levels of monocytes activation markers such as sCD14 and sCD163 are associated with increased all-cause mortality and HIV progression, as well as more rapid progression of carotid atherosclerosis, aortic inflammation and non-calcified coronary plaque [Kelesidis JID 12, Subramanian S, JAMA 12, Burdo JID 11]. There is some evidence that monocyte profile in untreated HIV infection mirrors those with acute coronary syndrome [Funderberg N Blood 12] and circulating monocytes CD16+ were associated with coronary artery calcium progression in the SUN cohort [Baker AIDS 14]. Data from the MACS cohort showed that elevated levels of monocyte activation markers (sCD163, sCD14 and CCL2) in HIV-infected men were associated with CAC and coronary artery stenosis [Mc Kibben RA J Infec Dis 15]. None of these studies have been performed in cardiovascular high-risk virologically suppressed patients.
HIV infection causes dramatic damage to the gastrointestinal (GI) tract that includes substantial disruption of gut microbiota composition with presence of microbes at higher pathogenic potential compared to less agressive indigenous organisms, and massive loss of gut-residing CD4+ T-cells (Brenchley NAT MED 2006, Gori J Clin Microbiol 2007, Douek Annu Rev Med 2009). Thus, a substantial breach of the anatomo-functional GI barrier occurs, with progressive failure of mucosal immunity and leakage into the systemic circulation of bacterial by-products, such as lipopolysaccharide (LPS) and bacterial DNA fragments which contribute to immune activation even in patients with good virologic control (Brenchley Nature Med 2006, Jiang JID 2009, Ferri JID 2010, Estes PLoS Pathog 2010). Microbial translocation is defined as the transfer of gut derived microbes and/or microbial products to systemic circulation without overt bacteremia. Different markers may be used in order to evaluate this phenomenon: 16S DNA, LPS or its soluble receptor LBP (LPS Binding Protein), sCD14 and I-FAB. These markers are not redundant because they describe different aspects of microbial translocation. For instance 16S DNA measures global presence of microbes in plasma, while LPS increase is mainly driven by gram negative bacteria.
Persistent immune activation has been implicated in risk of cardiovascular disease in HIV infection and should receive as much attention as traditional CVD risk factors and ART (Currier AIDS 2005, Friis-Moller NEJM 2003, Subramanian JAMA 2012, Shaked Arterioscler Thromb Vasc Biol 2014, Kelesidis JID 2012). There are some reports associating LPS with subsequent cardiovascular disease in HIV-infected patients (Pedersen 2013 Kelesidis JID 2012). Increased levels of CD14s that persist in some treated HIV have been associated to an increased all-cause mortality and HIV progression, as well as more rapid progression of carotid atherosclerosis (Kelesidis T at al CROI 2012 Seattle). sCD163, a marker of monocyte and macrophage activation, has been significantly correlated with aortic inflammation (Subramanian S, JAMA 2012). Associations of one or more markers of microbial translocation with characteristics of coronary injuries (stenosis, volume, mass and type of coronary plaques) have not yet been studied.
- Conditions
- Virus-HIV
- Being tested
- blood test
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testBiological
Additional 21 ml of blood will be collected
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected patients | Other | HIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART and HIV-RNA < 50 copies >= 12 months (one blip allowed) As part of this research, three additional tubes of blood (EDTA) will be taken from patients (21 mL) during blood tests performed as part of a scheduled consultation for the management of their pathology Receives: Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary computed tomographic angiography (CCTA)
Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.
Measured: 1 month
Secondary outcomes (5)
Lymphocyte immune activation
Lymphocyte immune activation (CD4+HLA-DR+, CD8+CD38+HLA-DR+)
Measured: 1 day
Lymphocyte immunosenescence
Lymphocyte immunosenescence (CD4+CD57+, CD8+CD57+ )
Measured: 1 day
Monocyte subpopulation
Monocyte subpopulation (CD16+ surface density) and activation markers (sCD163, sCD14, CCL2)
Measured: 1 day
Microbial translocation
Microbial translocation (16S DNA, LBP, I-FAB and sCD14)
Measured: 1 day
Inflammation
Inflammation (CRP, sTNFR1, IL-6, D-dimers)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Why it stopped: Departure of the coordinating investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus-HIVStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Hospital General Universitario Reina Sofía de Murcia, Hospital Vall D' Hebron Barcelon, University Hospital of Patras
- Responsible party
- Sponsor
- Investigators
- Christina PSOMAS, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898896
- Sponsor's protocol ID
- 9642
- Status last verified
- Aug 2019
- First submitted
- 8 Sep 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Obstructive Coronary Artery Disease (CAD) in Suppressed HIV-infected Patients ≥ 45 Years and 2 or More CV Risk Factors. Associations With Persistent Immune Activation and Microbial Translocation
- ClinicalTrials.gov ID
- NCT02898896
- Acronym / sponsor ID
- 9642
- Conditions
- Virus-HIV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the coordinating investigator
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Hospital General Universitario Reina Sofía de Murcia, Hospital Vall D' Hebron Barcelon, University Hospital of Patras
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 13 Sep 2016 (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.
HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation
Detailed description
A hallmark of HIV infection is a state of global immune activation that is only partially restored under highly active antiretroviral therapy. Apart from immune deficiency and impaired immune restoration, this chronic immune activation may result via various mechanisms in non-AIDS linked morbidities such as atherosclerosis. Coronary artery disease (CAD), especially myocardial infarction (MI), is the leading cause of death in Europe [Eurostat 2013]. Cardiovascular deaths are responsible for 8% of deaths among HIV-infected patients in France and for 15% of deaths among HIV-infected patients in US [Lewden C JAIDS 08, Palella FJ JAIDS 06]. Multiple cohort studies have shown that HIV-infected patients are at a higher risk of myocardial infarction than the general population [Triant VA J Clin Endocrinol 07, Freiberg MS JAMA Intern Med 13] and there is some evidence that HIV-infected patients have a 38% greater risk of mortality from MI than controls [Pearce D AM J Cardiol 12].
Several tools for cardiovascular risk stratification are available but current risk scores seem to underestimate this risk in HIV-infected patients. Indeed, a significant proportion of cardiovascular events occur in subjects with none or few risk factors. A European study comparing first episode of MI among HIV-infected patients with uninfected controls showed that 40% had none or only one traditional cardiovascular risk factor [Boccara F Eur Heart J 11]. Another study in general population demonstrates that almost 50% of patients with a MI had no previous history of coronary symptoms [Tunstall-Pedoe H Circulation 96].
The true prevalence of CAD in asymptomatic HIV-infected patients is unknown. Older studies performed in tissue samples from deceased patients demonstrated 3-times greater odds of having obstructive CAD in HIV-infected patients compared with non-infected controls after controlling for age and sex [Micheletti RG Cardiovasc Pathol 09]. A recent meta-analysis shows that the prevalence of coronary stenosis and calcified coronary plaques is similar in comparison with non-HIV age and sex-matched controls but HIV-infected patients have a 3-fold higher prevalence of non-calcified coronary plaques [D'Ascenzo Atherosclerosis 15].
CAD severity detected by coronary computed tomographic angiography (CCTA) is associated with cardiac death or MI and all-cause mortality [Habib F Int J Cardiol 12]. 64 slice or greater CCTA is reported to have a sensitivity of 93 to 97% and specificity of 80 to 90% compared to standard coronary angiography [Fihn SD J Am Coll Cardiol 12]. There is a high correlation between CCTA and invasive coronary angiography in the determination of CAD extent and severity [Miller JM N Engl J Med 08].
Whether routine CCTA screening in high-risk populations can effect changes in treatment (such as pre-emptive coronary revascularization or more aggressive medical therapy) remains unproven. The 2013 AHA guidelines about stable ischemic heart disease states that either stress test or anatomic imaging in higher-risk individuals may be appropriate [J Am Coll Cardiol 14].
Few studies using CCTA have been performed in HIV-infected patients and none of these have been done in intermediate-high risk populations. Most of theses studies have shown an increased prevalence of non-calcified plaques in HIV-infected men (59% vs. 34%) compared with controls non infected with similar CVRF [Lo J AIDS 10, Post W Ann Intern Med 14]. There is some inconsistent data regarding clinical variables associated with coronary stenosis. Meanwhile CD4 nadir, use or ART for more than 10 years and detectable viral load were independently associated with coronary stenosis > 50% in the MACS cohort study [Post W Ann Intern Med 14], another study among African-Americans with HIV only cardiovascular risk factors and cocaine use were associated with coronary stenosis [Lai S Clin Infec Dis 08] Although the epidemiology and pathogenesis of HIV associated cardiovascular disease are complex and controversial we know that the risk of cardiovascular events is higher in untreated than treated HIV infection, probably because inflammation is increased in untreated infection. Recent data have raised interest in the role of Monocytes/macrophages in HIV-associated cardiovascular disease. Increased levels of monocytes activation markers such as sCD14 and sCD163 are associated with increased all-cause mortality and HIV progression, as well as more rapid progression of carotid atherosclerosis, aortic inflammation and non-calcified coronary plaque [Kelesidis JID 12, Subramanian S, JAMA 12, Burdo JID 11]. There is some evidence that monocyte profile in untreated HIV infection mirrors those with acute coronary syndrome [Funderberg N Blood 12] and circulating monocytes CD16+ were associated with coronary artery calcium progression in the SUN cohort [Baker AIDS 14]. Data from the MACS cohort showed that elevated levels of monocyte activation markers (sCD163, sCD14 and CCL2) in HIV-infected men were associated with CAC and coronary artery stenosis [Mc Kibben RA J Infec Dis 15]. None of these studies have been performed in cardiovascular high-risk virologically suppressed patients.
HIV infection causes dramatic damage to the gastrointestinal (GI) tract that includes substantial disruption of gut microbiota composition with presence of microbes at higher pathogenic potential compared to less agressive indigenous organisms, and massive loss of gut-residing CD4+ T-cells (Brenchley NAT MED 2006, Gori J Clin Microbiol 2007, Douek Annu Rev Med 2009). Thus, a substantial breach of the anatomo-functional GI barrier occurs, with progressive failure of mucosal immunity and leakage into the systemic circulation of bacterial by-products, such as lipopolysaccharide (LPS) and bacterial DNA fragments which contribute to immune activation even in patients with good virologic control (Brenchley Nature Med 2006, Jiang JID 2009, Ferri JID 2010, Estes PLoS Pathog 2010). Microbial translocation is defined as the transfer of gut derived microbes and/or microbial products to systemic circulation without overt bacteremia. Different markers may be used in order to evaluate this phenomenon: 16S DNA, LPS or its soluble receptor LBP (LPS Binding Protein), sCD14 and I-FAB. These markers are not redundant because they describe different aspects of microbial translocation. For instance 16S DNA measures global presence of microbes in plasma, while LPS increase is mainly driven by gram negative bacteria.
Persistent immune activation has been implicated in risk of cardiovascular disease in HIV infection and should receive as much attention as traditional CVD risk factors and ART (Currier AIDS 2005, Friis-Moller NEJM 2003, Subramanian JAMA 2012, Shaked Arterioscler Thromb Vasc Biol 2014, Kelesidis JID 2012). There are some reports associating LPS with subsequent cardiovascular disease in HIV-infected patients (Pedersen 2013 Kelesidis JID 2012). Increased levels of CD14s that persist in some treated HIV have been associated to an increased all-cause mortality and HIV progression, as well as more rapid progression of carotid atherosclerosis (Kelesidis T at al CROI 2012 Seattle). sCD163, a marker of monocyte and macrophage activation, has been significantly correlated with aortic inflammation (Subramanian S, JAMA 2012). Associations of one or more markers of microbial translocation with characteristics of coronary injuries (stenosis, volume, mass and type of coronary plaques) have not yet been studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected patients | Other | Biological: blood testHIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART and HIV-RNA < 50 copies >= 12 months (one blip allowed) As part of this research, three additional tubes of blood (EDTA) will be taken from patients (21 mL) during blood tests performed as part of a scheduled consultation for the management of their pathology |
Who may qualify
- Ages
- 48 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART HIV-RNA < 50 copies >= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months
Key exclusion criteria (1 listed)
- Previous CV event (MI, stroke, unstable angina, CABG) Atrial fibrillation Chronic kidney disease [eGFR < 60ml/min MDRD or CKD-Epi) Unstable liver disease History of IV contrast allergy Chronic inflammatory disorders apart from HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testAdditional 21 ml of blood will be collected | Biological | HIV-infected patients |
Primary outcome
coronary computed tomographic angiography (CCTA)
Time frame: 1 month
Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.
5 secondary outcomes
Lymphocyte immune activation
Time frame: 1 day
Lymphocyte immunosenescence
Time frame: 1 day
Monocyte subpopulation
Time frame: 1 day
Microbial translocation
Time frame: 1 day
Inflammation
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Departure of the coordinating investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Christina PSOMAS study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test in people with Virus-HIV, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Aug 2019. 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 France. 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 was stopped early (reason given: Departure of the coordinating investigator). Results are not available in the source record.
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?
coronary computed tomographic angiography (CCTA) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2019.