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

Официальное название

Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: each 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Ospedale San Raffaele — Milan

Публикации

• Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2026 Feb 18;233(2):247-256. doi: 10.1093/infdis/jiaf461. PMID 40990223
• Clemente T, Pontillo D, Malagnino V, Calza L, Di Biagio A, Cenderello G, Lolatto R, Manzillo E, Moioli MC, De Socio GV, Castagna A, Spagnuolo V; the PRESTIGIO Study Group. Cancer in people with multidrug-resistant HIV. AIDS. 2024 Oct 1;38(12):1801-1806. doi: 10.1097/QAD.0000000000003952. Epub 2024 Aug 29. PMID 39206886
• Clemente T, Galli L, Lolatto R, Gagliardini R, Lagi F, Ferrara M, Cattelan AM, Foca E, Di Biagio A, Cervo A, Calza L, Maggiolo F, Marchetti G, Cenderello G, Rusconi S, Zazzi M, Santoro MM, Spagnuolo V, Castagna A; PRESTIGIO Study Group. Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors. PMID 38341206
• Rusconi S, Saladini F, Bellocchi MC, Galli L, Gagliardini R, Gazzola L, Francisci D, Vichi F, Foca E, Zazzi M, Santoro MM, Gabrieli A, Castagna A; PRESTIGIO Registry study group; PRESTIGIO Registry Steering Committee: Antonella Castagna (coordinator); Stefano Bonora; Leonardo Calza; Antonella Castagna; Giovanni Cenderello; Adriana Cervo; Giulio Maria Corbelli; Antonio Di Biagio; Emanuele Foca; Rob PMID 34999223

Идентификаторы

NCT: NCT04098315 · PRESTIGIO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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