COVID-19 Infection in Patients Infected With HIV and/or on PrEP

Completed

• Conditions: Pre-exposure Prophylaxis; HIV

• Registration Number: NCT04379245
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.

In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.

The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.

Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-30
• Primary Completion: 2020-04-30
• Status Verified: 2020-05
• Study Completion: 2020-05-04
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

• HIV patients in Hospices Civils de Lyon
• on-PrEP patients in Hospices Civils de Lyon

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Covid attack rate	During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation	Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data using the unique identification number in the 2 databases. This cross-checking of files will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

Trial Locations

Locations (1)

Croix-Rousse Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France