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

Condition(s) studied

Investigational drug(s) / intervention(s)

REGISTER CREATION: Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.

Study 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.

Eligibility

Primary outcome measure(s)

• 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. — 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; * death.

Trial sites (1)

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