Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
NCT04098315 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-05-07
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.
Conditions
- HIV-1-infection
- Multi-Antiviral Resistance
Interventions
- OTHER
-
REGISTER CREATION
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
Sponsors & Collaborators
-
ViiV Healthcare
collaborator INDUSTRY -
Castagna Antonella
lead OTHER
Principal Investigators
-
Antonella Castagna · san raffaele
Eligibility
- Min Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-14
- Primary Completion
- 2020-03-31
- Completion
- 2028-12-31
Countries
- Italy
Study Locations
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