COVID-19 Prevalence in HIV-infected Patients

NCT04515225 | Unknown

• 1 other identifier: 7947
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-infection; AIDS; antiretroviral treatment; CD4 cell count; plasma HIV; RNA; SARS-CoV-2; antibodies

Outcome Measures

Primary Outcomes (1)

• Seroprevalence of SARS-CoV-2

  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.

  From baseline to 12 months

Study Arms (1)

HIV-infected patients

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

Other: Blood Sample

Interventions

Blood Sample OTHER

Blood Sample

HIV-infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected patients on follow-up in a single University Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: November 4, 2020
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)