Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGISTER CREATION.
- Who it may be relevant to
- Registry conditions: HIV-1-infection, Multi-Antiviral Resistance. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)
Overview
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 long-term effectiveness of different antiretroviral regimes; * evolution of the genotype and phenotypic susceptibility of antiretroviral drugs used in patients with virological failure; * mortality; * incidence of opportunistic AIDS-related infections and chronic conditions (comorbidity); * determinants of clinical outcomes including virological/immunological/inflammatory markers. * antiretroviral therapy (ART) compliance and health assessments; * drug-economy indications related to the clinical management of this complex sub-population.
Detailed description
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.
Interventions
- Other REGISTER CREATION
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
Primary outcome measures
- 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. [Time frame: each 1 year]
Eligibility criteria
Inclusion criteria
- subjects with HIV-1 infection;
- age >14 years;
- documented resistance to the 4 classes of antiretroviral drugs (NRTI, NNRTI, PI, INI), defined as resistance (at least intermediate) to at least one of the drugs in each class according to the Stanford algorithm. Resistance can be documented either at the time of inclusion in the study or previously documented throughout the patient's therapeutic history.
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Ospedale San Raffaele — Milan
Publications
- Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2026 Feb 18;233(2):247-256. doi: 10.1093/infdis/jiaf461. PMID 40990223
- Clemente T, Pontillo D, Malagnino V, Calza L, Di Biagio A, Cenderello G, Lolatto R, Manzillo E, Moioli MC, De Socio GV, Castagna A, Spagnuolo V; the PRESTIGIO Study Group. Cancer in people with multidrug-resistant HIV. AIDS. 2024 Oct 1;38(12):1801-1806. doi: 10.1097/QAD.0000000000003952. Epub 2024 Aug 29. PMID 39206886
- Clemente T, Galli L, Lolatto R, Gagliardini R, Lagi F, Ferrara M, Cattelan AM, Foca E, Di Biagio A, Cervo A, Calza L, Maggiolo F, Marchetti G, Cenderello G, Rusconi S, Zazzi M, Santoro MM, Spagnuolo V, Castagna A; PRESTIGIO Study Group. Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors. PMID 38341206
- Rusconi S, Saladini F, Bellocchi MC, Galli L, Gagliardini R, Gazzola L, Francisci D, Vichi F, Foca E, Zazzi M, Santoro MM, Gabrieli A, Castagna A; PRESTIGIO Registry study group; PRESTIGIO Registry Steering Committee: Antonella Castagna (coordinator); Stefano Bonora; Leonardo Calza; Antonella Castagna; Giovanni Cenderello; Adriana Cervo; Giulio Maria Corbelli; Antonio Di Biagio; Emanuele Foca; Rob PMID 34999223
Identifiers
NCT: NCT04098315 · PRESTIGIO