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Not yet recruitingNCT06747754HIVDBUpdated Dec 24, 2024

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

An observational study in HIV Infections, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,900
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 4,900 is above the median of 200 across 731 observational studies indexed under HIV Infections.

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Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Subjects with HIV infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • lack of willingness to provide free and informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,900 participants (estimated)
Patient registry
No

Interventions

  • OtherEstablishment 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.

    Also known as: Database

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What researchers measure

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.

    Time frame: 5 years

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive
    Rome, Lazio 00168, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Dec 2030, 71 months later.

Of 183 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 71 months is above that.

Counting every sponsor, half of 204 studies reached it within 38 months; a quarter within 17 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2024
First posted
Dec 24, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06747754
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 24, 2024

Study contacts

Carlo Torti, Prof
Contact
carlo.torti@policlinicogemelli.it
00390630154945
Francesca Lombardi, Dr
Contact
francesca.lombardi@policlinicogemelli.it
Carlo Torti
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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