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NCT04575545 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04575545
Other study ID # 2020-A02018-31
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2020
Est. completion date April 2022

Study information
Verified date September 2020
Source Hôpital Européen Marseille
Contact Myriam BENNANI
Phone 0413428351
Email m.bennani@hopital-europeen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date April 2022
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serology test for COVID-19
ELISA test

Locations
Country Name City State
France BENNANI Marseille

Sponsors (1)
Lead Sponsor Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary % of patients with positive serological tests for covid-19 3 months
Secondary Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19 % of anti-covid positive cells 3 months
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