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HIV Database (DBHIV)-Establishment of a Database of HIV Patients

NCT ID: NCT06747754

Last Updated: 2024-12-24

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

NOT_YET_RECRUITING

Total Enrollment

4900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2030-12-31

Brief Summary

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In Italy, there are over 90,000 patients with HIV-1 infection on antiretroviral therapy (ART). The availability of different classes of antiretroviral drugs (nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease, and the number of HIV-infected patients over 50 years of age has increased significantly and the number of elderly subjects is progressively increasing. Furthermore, HIV infection seems to accelerate the aging process, causing immune system dysfunction, excess oxidative stress and increased inflammatory processes (inflammaging).

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Establishment of a Database of HIV Patients

Establishment of a database that allows for systematic and continuous collection of data relating to clinical, laboratory and treatment characteristics of patients with HIV-1 for research purposes.

Intervention Type OTHER

Other Intervention Names

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Database

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Patients with chronic HIV infection (certified by a positive test for the detection of anti-HIV antibodies)
* Ability to sign the informed consent or signature of the declaration in lieu of consent in the case of deceased patients

Exclusion Criteria

* lack of willingness to provide free and informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlo Torti

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive

Rome, Lazio, Italy

Site Status

Countries

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Italy

Central Contacts

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Carlo Torti, Prof

Role: CONTACT

Phone: 00390630154945

Email: [email protected]

Francesca Lombardi, Dr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Carlo Torti

Role: primary

Other Identifiers

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ID6741

Identifier Type: -

Identifier Source: org_study_id