HIV Database (DBHIV)-Establishment of a Database of HIV Patients
HIVDB
Database HIV (DBHIV)-Costituzione di un Database di Pazienti HIV.
1 other identifier
observational
4,900
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2024
CompletedFirst Posted
Study publicly available on registry
December 24, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
December 24, 2024
December 1, 2024
6 years
December 18, 2024
December 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Establishment of a database
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.
5 years
Interventions
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.
Eligibility Criteria
Subjects with HIV infection
You may qualify if:
- 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
You may not qualify if:
- lack of willingness to provide free and informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive
Rome, Lazio, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Torti
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2024
First Posted
December 24, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
December 24, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share