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| Name | Class |
|---|---|
| Centre Hospitalier Intercommunal Villeneuve St Georges | UNKNOWN |
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This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection.
The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.
The symptomatic management of COVID-19 infections is currently at the forefront. The therapeutic efficacy of certain molecules is being evaluated in studies, in vitro and in vivo, such as remdesivir, hydroxychloroquine / chloroquine, and lopinavir / ritonavir. The latter has been used in the treatment of HIV for many years, like other PIs such as darunavir and atazanavir. In France, around 11% of PLWHIV are treated with long-term PIs.
Lopinavir / ritonavir has an inhibitory role on the protein endopeptidase of coronavirus C30 (CEP_C30). In humans, Cao et al did not demonstrate any superiority of efficacy of lopinavir / ritonavir compared to the control group receiving standard care (HR for clinical improvement: 1.24 (0.90-1, 72)), but the initiation of treatment in the study was mainly at late stages. Early initiation of lopinavir/r at the onset of SARS symptoms appears to be more effective. To our knowledge, the other PIs are under study, with a possible inhibition of the proteases of type-3-chemotrypsin or of the papain type of SARS-Cov2. Three open randomized studies in humans are underway in China, Spain, and Thailand. The question arises as to whether treatment with PIs could have a preventive role for COVID-19 infection, especially since PLWHIV have not been described as more at risk of developing COVID-19 infection.
The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.
This is a prospective multicenter cohort study. A random sample of 794 eligible individuals will be recruited from April 2020, consisting of 397 patients in the long-term PIs group and 397 patients in the long-term ARV regimen without PIs. The study will be offered to PLWHIV in Île-de-France, treated with long-term antiretroviral drugs with or without protease inhibitors.
For those who accept: i) they will receive phone calls (teleconsultation) to collect information regarding symptoms at M0, M1 and between M3 and M6 by a medical or paramedical person from their hospital center ; ii) in case of a high probability of infection with Covid-19, an on-site consultation will be offered to them, with a diagnostic test by PCR on a nasopharyngeal swab and eventually a chest scanner if indicated ; iii) a serology on a blood sample will be performed at the end of the epidemics to look for anti-COVID-19 antibodies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protease inhibitor exposed | HIV patients treated with antiretroviral drugs including a protease inhibitor |
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| Protease inhibitor non exposed | HIV patients treated with antiretroviral drugs without a protease inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the incidence of COVID-19 infection in PLWHIV treated with long-term antiretroviral drugs including a protease inhibitor and those without a protease inhibitor | Occurrence of COVID-19 infection during the epidemics (M0, M1) in both study groups | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the seroprevalence of COVID-19 infection in both groups of the study | Percentage of positive serological tests at the end of the epidemics in both study groups | 6 months |
| Comparison of the severity of COVID-19 infection symptoms in both groups of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be proposed to HIV patients treated with long-term antiretroviral drugs (ARDs) with or without protease inhibitors (PIs).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Créteil | Créteil | 94000 | France | |||
| CHU Henri Mondor |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Proportion of severe forms in both study groups |
| 6 months |
| Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor | Statistical association between a risk factor and the occurrence of COVID-19 infection in both study groups | 6 months |
| Créteil |
| 94010 |
| France |
| Centre hospitalier de Melun (GHSIF) | Melun | 77000 | France |
| Hopital universitaire de Hotel Dieu | Paris | 75004 | France |
| Hopital Universitaire de Necker | Paris | 75015 | France |
| CHI Villeneuve St Georges | Villeneuve-Saint-Georges | 94190 | France |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |