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NCT Number: NCT04098315

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

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.

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Key information

Conditions

HIV-1-infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Multi-Antiviral Resistance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, MI, 20127, Italy

Location status: Recruiting

Location contact

Antonella Castagna

CONTACT

[email protected]

0226437934

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGISTER CREATION

Other

Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Castagna

CONTACT

[email protected]

0226437934

Sponsors and collaborators

Lead sponsor

Castagna Antonella

Other

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Acronym: PRESTIGIO

Important dates

Study start
2017
Primary completion
2020
Study completion
2028
First posted
Sep 23, 2019
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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