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

HIV-1-infection Clinical Trial

— PRESTIGIO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098315
• Other study ID #: PRESTIGIO
• Status: Recruiting
• Start date: December 14, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: IRCCS San Raffaele
• Contact: Antonella Castagna
• Phone: 0226437934
• Email: castagna.antonella1[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan	MI

Sponsors (2)

Lead Sponsor	Collaborator
Castagna Antonella	ViiV Healthcare

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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

External Links

•   REGISTER E-CRF WEBSITE