Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575545
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hôpital Européen Marseille

Brief Summary:
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.

Condition or disease Intervention/treatment
Covid19 Virus-HIV Diagnostic Test: Serology test for COVID-19

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV positive patients Diagnostic Test: Serology test for COVID-19
ELISA test

Patients taking PrEP Diagnostic Test: Serology test for COVID-19
ELISA test




Primary Outcome Measures :
  1. % of patients with positive serological tests for covid-19 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19 [ Time Frame: 3 months ]
    % of anti-covid positive cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients infected by the HIV on treatment and patients taking PreP
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years
  • patients infected by the HIV on treatment
  • patients taking PreP (Pre-exposure prophylaxis (PrEP))
  • Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:

  • Subject to a measure for the protection of justice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575545


Contacts
Layout table for location contacts
Contact: Myriam BENNANI 0413428351 m.bennani@hopital-europeen.fr

Locations
Layout table for location information
France
BENNANI
Marseille, France, 13003
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Layout table for investigator information
Principal Investigator: Patrick PHILIBERT Hôpital Europeen Marseille
Layout table for additonal information
Responsible Party: Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT04575545    
Other Study ID Numbers: 2020-A02018-31
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases