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

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.

Completed

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Key information

Conditions

HIV Pre-exposure Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Data research, database analysis

Other

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)).

Primary outcomes

Covid attack rate

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: COVIDHIVPrEP

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 7, 2020
Registry last updated: May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed