Markers of Neurological Damage Post Covid-19 in PLWH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Markers of Neurological Damage Post Covid-19 in People Living With HIV (PLWH)

Conditions
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Hiv, COVID-19

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV + COVID+<br> | |
| HIV + COVID -<br> | |
| HIV - COVID +<br> | |
| HIV- COVID-<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on neurological damage of COVID-19 in PLWH | Assessing the impact of COVID-19 in PLWH concerning the neurological damage, by measuring blood's markers like the Neurofilament Light Protein (NfL) and the Glial Fibrillary Acidic Protein (gFAP) | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of neurocognitive and muscular (strength and balance) impairment | Assessing the prevalence of: neurocognitive impairment, altered muscular function (strenght and balance), plasmatic level of Ubiquitin Carboxy-terminal Hydrolase L1 Neurons (UCH-L1) and total-tau, soluble and cellular infiammation's markers in blood and the expression profile of messenger ribonucleic acid (mRNA) in lymphocytes and the humoral and cellular answer against Sars-CoV2 in people living with HIV which had and ad not contract COVID-19 | Through study completion, an average of 1 year |