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Abstract：
OBJECTIVE: The PRESTIGIO Registry was established in 2017 to collect clinical, virological and immunological monitoring data from people living with HIV (PLWH) with documented four-class drug resistance (4DR). Key research purposes include the evaluation of residual susceptibility to specific antiretrovirals and the validation of treatment and monitoring strategies in this population.
METHODS: The PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry.
RESULTS: The open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples.
UNASSIGNED: The registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole.
BACKGROUND: NCT04098315.
METHODS: The PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry.
RESULTS: The open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples.
UNASSIGNED: The registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole.
BACKGROUND: NCT04098315.
摘要：
目的：PRESTIGIO注册成立于2017年，目的是收集临床，来自HIV感染者（PLWH）的病毒学和免疫学监测数据，记录有四类耐药性（4DR）。主要研究目的包括评估对特定抗逆转录病毒药物的残留敏感性，以及验证该人群的治疗和监测策略。
方法：PRESTIGIO注册中心收集年度血浆和外周血单核细胞样本，临床,病毒学,来自PLWH的治疗和实验室数据跟踪了39个意大利临床中心，其特征是对≥1种核苷逆转录酶抑制剂的中高基因型耐药性，≥1种非核苷类逆转录酶抑制剂,≥1种蛋白酶抑制剂，加上对≥1种整合酶链转移抑制剂（INSTIs）的中高基因型耐药或含INSTI方案的病毒学失败史。迄今为止,该队列中已记录了229人。大多数数据是从4DR（基线）的第一个证据之日起收集的，回顾性获得一些基线前信息。从注册之日起收集样品。
结果：开放式队列已用于评估（1）与AIDS相关或非AIDS相关临床事件的生存或发展方面的预后；（2）不同抗逆转录病毒方案的长期疗效和安全性以及（3）可预测临床结果和治疗效果的病毒学和免疫学因素，特别是通过分析血浆和细胞样本。
■注册中心可以提供有关如何实施综合方法来研究PLWH的新知识，该方法对四种主要抗逆转录病毒类别具有已记录的耐药性，个体数量有限的人群，其特征是治疗管理的高度脆弱和复杂性。鉴于PLWH数据的预定年度更新，在注册管理机构中合作的研究人员可以随时向注册管理机构的指导委员会发送研究提案，它每3个月评估研究是否可以对注册表中的数据和生物样本进行研究，以及它们是否旨在更好地了解特定的健康状况，合并症的出现或可能对疾病进展和生活质量有影响的潜在治疗或实验药物的效果。最后,研究应该以包容性为目标，创新，并与社区和整个社会保持联系。
背景：NCT04098315。
方法：PRESTIGIO注册中心收集年度血浆和外周血单核细胞样本，临床,病毒学,来自PLWH的治疗和实验室数据跟踪了39个意大利临床中心，其特征是对≥1种核苷逆转录酶抑制剂的中高基因型耐药性，≥1种非核苷类逆转录酶抑制剂,≥1种蛋白酶抑制剂，加上对≥1种整合酶链转移抑制剂（INSTIs）的中高基因型耐药或含INSTI方案的病毒学失败史。迄今为止,该队列中已记录了229人。大多数数据是从4DR（基线）的第一个证据之日起收集的，回顾性获得一些基线前信息。从注册之日起收集样品。
结果：开放式队列已用于评估（1）与AIDS相关或非AIDS相关临床事件的生存或发展方面的预后；（2）不同抗逆转录病毒方案的长期疗效和安全性以及（3）可预测临床结果和治疗效果的病毒学和免疫学因素，特别是通过分析血浆和细胞样本。
■注册中心可以提供有关如何实施综合方法来研究PLWH的新知识，该方法对四种主要抗逆转录病毒类别具有已记录的耐药性，个体数量有限的人群，其特征是治疗管理的高度脆弱和复杂性。鉴于PLWH数据的预定年度更新，在注册管理机构中合作的研究人员可以随时向注册管理机构的指导委员会发送研究提案，它每3个月评估研究是否可以对注册表中的数据和生物样本进行研究，以及它们是否旨在更好地了解特定的健康状况，合并症的出现或可能对疾病进展和生活质量有影响的潜在治疗或实验药物的效果。最后,研究应该以包容性为目标，创新，并与社区和整个社会保持联系。
背景：NCT04098315。
