Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease. (PRESTIGIO)

May 5, 2025 updated by: Castagna Antonella

Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
each 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castagna Antonella

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Antonella Castagna, San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2017

Primary Completion (Actual)

March 31, 2020

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRESTIGIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared in scientific conferences and meetings.

IPD Sharing Time Frame

Data will become available after 1 year from the first visit first patient (FVFP) and they will be available until patients registry will be updated.

IPD Sharing Access Criteria

Must to be a partecipant of the registry.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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