Coronary Artery Disease (CAD) in Patients HIV-infected (CoroVIH)

January 18, 2022 updated by: Hôpital Européen Marseille

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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

  • France
      • Marseille, France, 13003
        • Recruiting
        • BENNANI
        • Principal Investigator:
          • Christina PSOMAS

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient VIH-1

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
microbial translocation (16S DNA)
24 months

Collaborators and Investigators

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

Sponsor

Hôpital Européen Marseille

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 (Actual)

September 7, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00219-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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