Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease. (PRESTIGIO)
|ClinicalTrials.gov Identifier: NCT04098315|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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;
- 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|
|HIV-1-infection Multi-Antiviral Resistance||Other: REGISTER CREATION|
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]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||5 Years|
|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 :||December 14, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||December 2022|
- Other: REGISTER CREATION
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
- 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;
Biospecimen Retention: Samples Without DNA
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/).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098315
|Contact: Antonella Castagnaemail@example.com|
|Ospedale San Raffaele||Recruiting|
|Milan, MI, Italy, 20127|
|Contact: Antonella Castagna 0226437934 firstname.lastname@example.org|
|Principal Investigator:||Antonella Castagna||San Raffaele|