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NCT04579146 Clinical Trial

Coronary Artery Disease (CAD) in Patients HIV-infected

HIV Infections Clinical Trial

— CoroVIH  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04579146
Other study ID # 2019-A00219-48
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 7, 2020
Est. completion date October 2023

Study information
Verified date January 2022
Source Hôpital Européen Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France BENNANI Marseille

Sponsors (1)
Lead Sponsor Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 24 months
Secondary 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) 24 months
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