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Markers of Neurological Damage Post Covid-19 in PLWH

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05719025
Acronym
NeuroCOV-HIV
Enrollment
200
Registered
2023-02-08
Start date
2022-10-24
Completion date
2023-10-31
Last updated
2023-02-08

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

Conditions

COVID-19, Hiv

Brief summary

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

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.

Interventions

None listed

Sponsors

Scientific Institute San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Impact on neurological damage of COVID-19 in PLWHThrough study completion, an average of 1 yearAssessing 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)

Secondary

MeasureTime frameDescription
Frequency of neurocognitive and muscular (strength and balance) impairmentThrough study completion, an average of 1 yearAssessing 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

Countries

Italy

Contacts

Primary ContactPaola Cinque, MD
cinque.paola@hsr.it+390226433160

Outcome results

None listed

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