Coronary Artery Disease (CAD) in Patients HIV-infected

An observational study of HIV Infections, run by Hôpital Européen Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 45 years and older
Conditions the study is for: HIV Infections
What is being tested?: coronary computed tomographic angiographic (CCTA)
How many people: 60 participants
Where: 1 siteFrance
Study dates: 7 Sep 2020to Oct 2023
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patient VIH-1

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

Sign of coronary pathology (chest pain, syncope, dyspnea).
ATCD of allergy to IV contrast agents
Chronic inflammatory disease other than HIV
Subject to a measure for the protection of justice

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

BENNANI
Marseille, 13003
Myriam BENNANI, 0413428351, m.bennani@hopital-europeen.fr
Christina PSOMAS
Recruiting

Other trials in France

About this study

Official title: ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY

Conditions: HIV Infections
Being tested: coronary computed tomographic angiographic (CCTA)
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

coronary computed tomographic angiographic (CCTA)Other
x-ray examination with contrast by a 64-slice CT coronary angiography.

Study groups in NCT04579146
Study group	Role	What they receive
HIV-1 patients and treated effectively for more than 12 months		X-ray examination with contrast by a 64-slice CT coronary angiography. Receives: Other: coronary computed tomographic angiographic (CCTA)

What is being measured

The primary outcome is the main question the study is designed to answer.

correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques
Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.
Measured: 24 months

Secondary outcomes (1)

Identify the bacterial populations constituting the intestinal microbiota in patients infected with HIV and look for a microbiotic signature in patients with subclinical atherothrombosis.
microbial translocation (16S DNA)
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 2020Oct 2023

First posted8 Oct 2020
Study start7 Sep 2020
Primary completionOct 2022 (estimated)
Study completionOct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
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 only
Time perspective: Prospective
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04579146
Sponsor's protocol ID: 2019-A00219-48
Acronym: CoroVIH
Status last verified: Jan 2022
First submitted: 24 Sep 2020
Last updated: 19 Jan 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial Phase: Syndemic Adapted Medly Uganda
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HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY
ClinicalTrials.gov ID: NCT04579146
Acronym / sponsor ID: CoroVIH / 2019-A00219-48
Conditions: HIV Infections
Study type: Observational
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Hôpital Européen MarseilleUniversity, hospital or other
Study start: 7 Sep 2020 (actual)
Primary completion: Oct 2022 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 8 Oct 2020 (actual)
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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HIV-1 patients and treated effectively for more than 12 months	–	Other: coronary computed tomographic angiographic (CCTA)X-ray examination with contrast by a 64-slice CT coronary angiography.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient VIH-1

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 (4 listed)

Sign of coronary pathology (chest pain, syncope, dyspnea).
ATCD of allergy to IV contrast agents
Chronic inflammatory disease other than HIV
Subject to a measure for the protection of justice

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
coronary computed tomographic angiographic (CCTA)x-ray examination with contrast by a 64-slice CT coronary angiography.	Other	HIV-1 patients and treated effectively for more than 12 months

Primary outcome

correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques
Time frame: 24 months
Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.

1 secondary outcome

Identify the bacterial populations constituting the intestinal microbiota in patients infected with HIV and look for a microbiotic signature in patients with subclinical atherothrombosis.
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
Individual participant dataSharing planned: No

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
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Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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HIV, Substance Use Disorder

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.

BENNANI

Marseille, France

0413428351

m.bennani@hopital-europeen.fr

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 Infections, run by Hôpital Européen Marseille 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 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques (time frame: 24 months). 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 NCT04579146.

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 19 Jan 2022.