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

Castagna Antonella

Status: Enrolling

Conditions: HIV-1-infection; Multi-Antiviral Resistance

Treatments: Other: REGISTER CREATION

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04098315

PRESTIGIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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