NCT04379245

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,200 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Pre-exposure Prophylaxis

Interventions

Type	Name	Description
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)).

Timeline

• Start date: 2020-04-30
• Primary completion: 2020-04-30
• Completion: 2020-05-04
• First posted: 2020-05-07
• Last updated: 2020-05-07

Locations

1 site across 1 country: France