An observational study in HIV-1-infection and Multi-Antiviral Resistance, sponsored by Castagna Antonella. Recruiting at 1 site in Italy. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Castagna Antonella · Observational
The PRESTIGIO Registry is an Observational, prospective, multicentre study that includes patients, regularly followed by Italian Infectious Disease Centres, with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI), and integrase inhibitors (INSTI).
Main objective of this register is to evaluate in the study population:
The PRESTIGIO Register consists of a systematic and continuous collection of data on clinical, laboratory and treatment characteristics of patients with documented resistance to the 4 classes of antiretroviral drugs that meet the defined inclusion and exclusion criteria.
All the clinical centres of Infectious Diseases of the different Italian regions can participate in the implementation of the Registry. Based on an analysis conducted on data collected in an AIFA register, established for the purpose of monitoring the use of dolutegravir (DTG) 50 mg Bis in Die (BID) and containing about 200 patients with the criteria specified in this protocol, the size currently conceivable for this register in Italy is about 300 patients.
The collection of clinical information and biological samples will begin once the Ethics Committee of the participating centers has approved the participation in the registry and will continue for at least three years.
Castagna Antonella is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The Italian PRESTIGIO register will include patients who are regularly monitored according to the principles of good clinical practice in the Italian Infectious Diseases Centres of all Italian regions.
Patients will be included in the registry once informed consent has been obtained (Annex 2) signed to allow for the recording and analysis of clinical/laboratory data and for the collection of biological samples, subject to the guarantee of anonymity and independence of therapeutic choices and clinical management, which will be the sole responsibility of the treating physician. The consent collected must be entered in the Register.
Exclusion Criteria:
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
Collection of date to evaluate: - Long-term effectiveness of different ART; -comorbidity and mortality; - ART compliance and health assessments; - drug-economy indications related to the clinical management.
to evaluate the characteristics of the study population, will be carry out specific observational studies with the following collected data: * demographic characteristics * clinical characteristics (HIV transmission mode, pre-ART viral load, CD4+ nadir, co-infection with hepatitis B and C viruses and previous treatments, previous AIDS events); * lifestyle factors * comorbidity (cancer, diabetes, cardiovascular disease, chronic kidney disease, liver disease, fractures and osteoporosis, cognitive dysfunction, COPD, sexually transmitted diseases); * antiretroviral and concomitant drugs; * adherence to antiretroviral therapy; * Laboratory parameters: CD4, CD8, HIV-RNA, lipids, glucose, liver and kidney parameters; * resistance tests for INSTI, NRTI, NNRTI, PI; * the historical genotypes (resistance and viral tropism) * any hospitalizations; * death.
Time frame: each 1 year
Plan to share: Yes — IPD will be shared in scientific conferences and meetings.
Supporting information: Study protocol, Icf, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Castagna Antonella