Markers of Neurological Damage Post Covid-19 in PLWH (NeuroCOV-HIV)

Scientific Institute San Raffaele

Status: Enrolling

Conditions: COVID-19; Hiv

Study type: Observational

Funder types: Other

Identifiers

NCT05719025

Neuro COV-HIV

Details and patient eligibility

About

Both HIV infection and Covid-19 are associated to cognitive and psychiatric impairment, like anxiety and depression. These disturbs are well-known in HIV infection and partially characterized in Covid-19.

Full description

HIV has an high neurotropism and the HIV-associated dementia was one of the most frequent clinical complications and principal cause of death before the introduction of antiretroviral theraphy (ART). However, also in PLWH taking ART and with suppressed viral load over years, the proportion of neuro-cognitive impairment, anxiety and depression remain higher then the general population.

These problems may be the consequence of a persistent systemic and central nervous system (CNS) immuno-activation caused by the persistence of viral reservoir in the peripheric and tissutal lymphocytes.

Neurological and psychiatric problems have been described in a variable proportion in patients with corona virus disease 19 (COVID-19) and in the complex it doesn't seems to be the direct consequence of CNS cellular infection, but rather of inflammation and coagulations disorder due to COVID-19 in the nervous tissue.

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV+ COVID+: people living with HIV that get corona virus disease 19 (COVID19) diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age > 50 years old, no gender.
• HIV+ COVID-: people living with HIV that had not get COVID19. Age>50 years; no gender.
• HIV- COVID+: people without HIV that get COVID19 diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age > 50 years old, no gender.
• HIV- COVID-: people without HIV that had not get COVID19 (healthy people and volunteers) Age>50 years; no gender.

Exclusion criteria

• Inability to perform the neuro-cognitive or functional tests due to neurologic deficit (inability to writing, reading, understand how to perform the tests)

Trial design

200 participants in 4 patient groups

HIV + COVID+

HIV + COVID -

HIV - COVID +

HIV- COVID-