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Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )

Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04357639
Enrollment
1040
Registered
2020-04-22
Start date
2020-05-28
Completion date
2021-07-31
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Patients

Keywords

Protease inhibitor, antiretroviral drug, COVID-19

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.

Interventions

OTHERNo intervention

No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection

Sponsors

Centre Hospitalier Intercommunal Villeneuve St Georges
CollaboratorUNKNOWN
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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 inhibitor1 monthOccurrence of COVID-19 infection during the epidemics (M0, M1) in both study groups

Secondary

MeasureTime frameDescription
Determination of the seroprevalence of COVID-19 infection in both groups of the study6 monthsPercentage 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 monthsProportion of severe forms in both study groups
Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor6 monthsStatistical association between a risk factor and the occurrence of COVID-19 infection in both study groups

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026