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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04379245

Collaborator

(none)

4,200

Enrollment

Location

Actual Duration (Days)

31959.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Pre-exposure Prophylaxis	Other: Data research, database analysis

Study Design

Study Type:

Observational

Actual Enrollment :

4200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor

Actual Study Start Date :

Apr 30, 2020

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

May 4, 2020

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04379245

Other Study ID Numbers:

CRC_GHN_2020_002

First Posted:

May 7, 2020

Last Update Posted:

May 7, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 7, 2020