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

Sponsor
Castagna Antonella (Other)
Overall Status
Recruiting
CT.gov ID
NCT04098315
Collaborator
ViiV Healthcare (Industry), Therathecnologies Inc. (Other)
300
Enrollment
1
Location
131.6
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: REGISTER CREATION

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Dec 14, 2017
Actual Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
Dec 1, 2028

Outcome Measures

Primary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale San Raffaele Milan MI Italy 20127

Sponsors and Collaborators

  • Castagna Antonella
  • ViiV Healthcare
  • Therathecnologies Inc.

Investigators

  • Principal Investigator: Antonella Castagna, San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Castagna Antonella, Sponsor and Principal Investigator, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT04098315
Other Study ID Numbers:
  • PRESTIGIO
First Posted:
Sep 23, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Castagna Antonella, Sponsor and Principal Investigator, Ospedale San Raffaele
HIV
AIDS
DRUG RESISTANCE

Study Results

No Results Posted as of Jan 11, 2022