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

HIV Clinical Trial

— COVIDHIVPrEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379245
• Other study ID #: CRC_GHN_2020_002
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4200
• Est. completion date: May 4, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV patients in Hospices Civils de Lyon

• on-PrEP patients in Hospices Civils de Lyon

Exclusion Criteria:

-

Related Conditions & MeSH terms

• HIV
• Infection
• Pre-exposure Prophylaxis

Intervention

Other:
• Data research, database analysis
Extraction of virological data at the virology laboratory (date, SARS-COV2 PCR result, identification number, sex, date of birth) (Excel file) Extraction of demographic and viro-immunological data from patients infected with HIV and on PrEP followed at the Hospices Civils de Lyon, France, over the period concerned (Access extraction) Data crossing (Excel / Access) and statistical analysis Calculation of the positivity rate per calendar period (= number of diagnosed cases / number of patients tested) and the attack rate per calendar period (number of diagnosed cases / number of people exposed (= active file of patients followed reduced by the number already known to be positive)).

Locations

Country	Name	City	State
France	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covid attack rate	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.	During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation