COVID-19 Prevalence in HIV-infected Patients

• Conditions: HIV Infections
• Interventions: Other: Blood Sample

• Registration Number: NCT04515225
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Study Start: 2020-11-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-10
• Primary Completion: 2022-05-03
• Study Completion: 2022-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• adults (> 18 years)
• HIV-infected patients
• subjects with social insurance
• subjects able to understand study purposes, and to give a written and informed consent

Exclusion Criteria :

• subjects unable to understand informations on the study, and to provide informed consent
• subjects under guardianship or curatorship
• subjects under judicial protection

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-infected patients	Blood Sample	All HIV-infected patients on active follow-up, whatever clinical and biological condition, on ARV treatment or not, and whatever ARV combination

Primary Outcome Measures

Name	Time	Method
Seroprevalence of SARS-CoV-2	From baseline to 12 months	SARS-CoV-2 antibodies will be detected with a rapid test detecting IgG and IgM, at inclusion, and during a 6-month and a 12-month visit, in order to assess the prevalence of the virus in this population.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France