{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T21:36:24Z","timestamp":1793223384564,"version":"4.5.0"},"reference-count":43,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,10]],"date-time":"2024-02-10T00:00:00Z","timestamp":1707523200000},"content-version":"unspecified","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,1,4]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>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 \u22651 nucleoside reverse transcriptase inhibitors, \u22651 non-nucleoside reverse transcriptase inhibitors, \u22651 protease inhibitors, plus either intermediate-to-high genotypic resistance to \u22651 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings to date<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Future plans<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04098315\">NCT04098315<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-080606","type":"journal-article","created":{"date-parts":[[2024,2,10]],"date-time":"2024-02-10T20:35:43Z","timestamp":1707597343000},"page":"e080606","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":24,"title":["Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04098315","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6548-3427","authenticated-orcid":false,"given":"Tommaso","family":"Clemente","sequence":"first","affiliation":[{"name":"Vita-Salute San Raffaele University, Milan, Italy"},{"name":"Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8046-0290","authenticated-orcid":false,"given":"Laura","family":"Galli","sequence":"additional","affiliation":[{"name":"Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2447-6498","authenticated-orcid":false,"given":"Riccardo","family":"Lolatto","sequence":"additional","affiliation":[{"name":"Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6351-2623","authenticated-orcid":false,"given":"Roberta","family":"Gagliardini","sequence":"additional","affiliation":[{"name":"National Institute for Infectious Diseases \u201cL. Spallanzani\u201d IRCCS, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0999-6070","authenticated-orcid":false,"given":"Filippo","family":"Lagi","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0377-9630","authenticated-orcid":false,"given":"Micol","family":"Ferrara","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2869-2945","authenticated-orcid":false,"given":"Anna Maria","family":"Cattelan","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Department of Molecular Medicine, Padua University Hospital, Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4395-5379","authenticated-orcid":false,"given":"Emanuele","family":"Foc\u00e0","sequence":"additional","affiliation":[{"name":"Unit of Infectious and Tropical Diseases, Department of Clinical and Experimental Sciences, ASST Spedali di Brescia, Brescia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1436-5089","authenticated-orcid":false,"given":"Antonio","family":"Di Biagio","sequence":"additional","affiliation":[{"name":"Clinic of Infectious Diseases, IRCCS Policlinico San Martino Hospital, University of Genoa, Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1384-7847","authenticated-orcid":false,"given":"Adriana","family":"Cervo","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Policlinico di Modena, Universit\u00e0 Degli Studi di Modena e Reggio Emilia, Modena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1895-1504","authenticated-orcid":false,"given":"Leonardo","family":"Calza","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Department of Medical and Surgical Sciences, S. 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