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

October 2, 2020 updated by: Hôpital Européen Marseille

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13003
        • BENNANI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients infected by the HIV on treatment and patients taking PreP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of patients with positive serological tests for covid-19
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Investigators

  • Principal Investigator: Patrick PHILIBERT, Hopital européen Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02018-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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