Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )
- Conditions
- HIV Patients
- Interventions
- Other: No intervention
- Registration Number
- NCT04357639
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1040
- HIV patients over 18 years of age
- Follow-up for an HIV infection 1 or 2
- Treated with antiretroviral drugs
- Resident in France during the epidemics
- No change in antiretroviral drugs during the epidemics
- No-opposition to participate to the research
- Patients under guardianship or curators
- Opportunistic classifying pathologies by the Control Disease Center (CDC)
- Patients unable to give a free and informed no-opposition consent to participate to the protocol
- Patients under safeguarding justice
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Protease inhibitor exposed No intervention HIV patients treated with antiretroviral drugs including a protease inhibitor Protease inhibitor non exposed No intervention HIV patients treated with antiretroviral drugs without a protease inhibitor
- Primary Outcome Measures
Name Time Method 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 1 month Occurrence of COVID-19 infection during the epidemics (M0, M1) in both study groups
- Secondary Outcome Measures
Name Time Method Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor 6 months Statistical association between a risk factor and the occurrence of COVID-19 infection in both study groups
Determination of the seroprevalence of COVID-19 infection in both groups of the study 6 months Percentage of positive serological tests at the end of the epidemics in both study groups
Comparison of the severity of COVID-19 infection symptoms in both groups of the study. 6 months Proportion of severe forms in both study groups
Trial Locations
- Locations (6)
Hopital Universitaire de Necker
🇫🇷Paris, France
CHU Henri Mondor
🇫🇷Créteil, France
Centre hospitalier de Melun (GHSIF)
🇫🇷Melun, France
CHI Créteil
🇫🇷Créteil, France
Hopital universitaire de Hotel Dieu
🇫🇷Paris, France
CHI Villeneuve St Georges
🇫🇷Villeneuve-Saint-Georges, France