Markers of Neurological Damage Post Covid-19 in PLWH

NCT ID: NCT05719025

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-24

Study Completion Date

2023-10-31

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.

Conditions

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COVID-19 Hiv

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV + COVID+

No interventions assigned to this group

HIV + COVID -

No interventions assigned to this group

HIV - COVID +

No interventions assigned to this group

HIV- COVID-

No interventions assigned to this group

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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Paola Cinque

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele Turro

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Cinque, MD

Role: CONTACT

+390226433160

Facility Contacts

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Paola Cinque, MD, Ph.D.

Role: primary

+3902264333160

Other Identifiers

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Neuro COV-HIV

Identifier Type: -

Identifier Source: org_study_id

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