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

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ClinicalTrials.gov Identifier: NCT04098315
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Castagna Antonella, Ospedale San Raffaele

Tracking Information
First Submitted Date September 16, 2019
First Posted Date September 23, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date December 14, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
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)
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples Without DNA
Description:

At enrolment, plasma and cell samples of peripheral blood mononuclear cells(PBMCs) are collected for subsequent virological and immunological investigations. The samples to be collected for each patient are: 6 plasma aliquots (1.5-2.0 ml/each) and 6 PBMC aliquots (3-5 million/each).

Sample collection should be repeated at the end of each subsequent year of follow-up.

The collected biological samples are sent to the biobank of the coordinating centre and stored in a biological bank with ISO 9001:2000 quality certification (Biorep srl, http://www.biorep.it/).

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.

Condition
  • HIV-1-infection
  • Multi-Antiviral Resistance
Intervention Other: REGISTER CREATION
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Antonella Castagna 0226437934 castagna.antonella1@hsr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04098315
Other Study ID Numbers PRESTIGIO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: IPD will be shared in scientific conferences and meetings.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: Must to be a partecipant of the registry.
URL: http://www.registroprestigio.com
Responsible Party Castagna Antonella, Ospedale San Raffaele
Study Sponsor Castagna Antonella
Collaborators ViiV Healthcare
Investigators
Principal Investigator: Antonella Castagna San Raffaele
PRS Account Ospedale San Raffaele
Verification Date September 2019