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

NCT04098315 | Recruiting

• 1 other identifier: PRESTIGIO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection; Multi-Antiviral Resistance

Keywords

HIV; AIDS; DRUG RESISTANCE

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  each 1 year

Interventions

REGISTER CREATION OTHER

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

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Italian PRESTIGIO register will include patients who are regularly monitored according to the principles of good clinical practice in the Italian Infectious Diseases Centres of all Italian regions. Patients will be included in the registry once informed consent has been obtained (Annex 2) signed to allow for the recording and analysis of clinical/laboratory data and for the collection of biological samples, subject to the guarantee of anonymity and independence of therapeutic choices and clinical management, which will be the sole responsibility of the treating physician. The consent collected must be entered in the Register.

You may qualify if:

• subjects with HIV-1 infection;
• age \>14 years;

You may not qualify if:

• none

Sponsors & Collaborators

• Castagna Antonella: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20127, Italy

RECRUITING

Related Publications (3)

• 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. 2025 Sep 24:jiaf461. doi: 10.1093/infdis/jiaf461. Online ahead of print.

  PMID: 40990223 DERIVED

• 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. BMJ Open. 2024 Feb 10;14(2):e080606. doi: 10.1136/bmjopen-2023-080606.

  PMID: 38341206 DERIVED

• 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; Roberta Gagliardini; Laura Galli; Riccardo Lolatto; Franco Maggiolo; Giulia Marchetti; Stefano Rusconi; Maria Santoro; Vincenzo Spagnuolo; Katia Sterrantino; Maurizio Zazzi. Leronlimab (PRO 140) in vitro activity against 4-class drug resistant HIV-1 from heavily treatment experienced subjects. Pharmacol Res. 2022 Feb;176:106064. doi: 10.1016/j.phrs.2022.106064. Epub 2022 Jan 6. No abstract available.

  PMID: 34999223 DERIVED

Related Links

• REGISTER E-CRF WEBSITE

Biospecimen

Retention: SAMPLES WITHOUT DNA

At enrolment, plasma and cell samples of peripheral blood mononuclear cells(PBMCs) are collected for subsequent virological and immunological investigations. The samples to be collected for each patient are: 6 plasma aliquots (1.5-2.0 ml/each) and 6 PBMC aliquots (3-5 million/each). Sample collection should be repeated at the end of each subsequent year of follow-up. The collected biological samples are sent to the biobank of the coordinating centre and stored in a biological bank with ISO 9001:2000 quality certification (Biorep srl, http://www.biorep.it/).

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Antonella Castagna

  san raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Castagna

CONTACT

0226437934; castagna.antonella1@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor and Principal Investigator

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 23, 2019
• Study Start: December 14, 2017
• Primary Completion: March 31, 2020
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will become available after 1 year from the first visit first patient (FVFP) and they will be available until patients registry will be updated.
• Access Criteria: Must to be a partecipant of the registry.

Locations

IT (1)