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COVID-19 Prevalence in HIV-infected Patients (SeCoVIHA)

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ClinicalTrials.gov Identifier: NCT04515225
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV Infections Other: Blood Sample

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
Blood Sample




Primary Outcome Measures :
  1. Seroprevalence of SARS-CoV-2 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
HIV-infected patients on follow-up in a single University Hospital
Criteria

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
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04515225    
Other Study ID Numbers: 7947
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
HIV-infection
AIDS
antiretroviral treatment
CD4 cell count
plasma HIV
RNA
SARS-CoV-2
antibodies
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases