Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
Recruiting · NCT04098315 · Observational (researchers observe without assigning treatment) · Lead sponsor: Castagna Antonella
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
1 location listed.
- Ospedale San Raffaele - Milan, MI, Italy