HIV-1-infectionPRESTIGIONCT04098315
Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
An observational study of HIV-1-infection and Multi-Antiviral Resistance, run by Castagna Antonella at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HIV-1-infection, Multi-Antiviral Resistance
- What is being tested?
- REGISTER CREATION
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2017to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20127
Antonella Castagna, 0226437934, castagna.antonella1@hsr.it
About this study
Official title: Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)
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.
Read the detailed description
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.
- Conditions
- HIV-1-infection, Multi-Antiviral Resistance
- Being tested
- REGISTER CREATION
- Keywords
- HIV, AIDS, DRUG RESISTANCE
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGISTER CREATIONOther
Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: each 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start14 Dec 2017
- Primary completion31 Mar 2020
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Castagna Antonella
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor-investigator, Castagna Antonella, IRCCS San Raffaele
- Investigators
- Antonella Castagna, Principal investigator, san raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098315
- Sponsor's protocol ID
- PRESTIGIO
- Acronym
- PRESTIGIO
- Status last verified
- May 2025
- First submitted
- 16 Sep 2019
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in scientific conferences and meetings.
Publications
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.
PubMed 40990223Spagnuolo V, Galli L, Li J, Dunn K, Lagi F, Gagliardini R, Sarmati L, Cattelan AM, Giacomelli A, Santoro MM, Zazzi M, Callebaut C, Castagna A, VanderVeen LA. Teropavimab and zinlirvimab sensitivity in people living with multidrug-resistant HIV-1: data from the PRESTIGIO Registry. Microbiol Spectr. 2025 Oct 7;13(10):e0277724. doi: 10.1128/spectrum.02777-24. Epub 2025 Sep 11.
PubMed 40932389Clemente 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.
PubMed 39206886Clemente 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.
PubMed 38341206Rusconi 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.
PubMed 34999223
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)
- ClinicalTrials.gov ID
- NCT04098315
- Acronym / sponsor ID
- PRESTIGIO / PRESTIGIO
- Conditions
- HIV-1-infection, Multi-Antiviral Resistance
- Keywords
- HIV, AIDS, DRUG RESISTANCE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Castagna AntonellaUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGISTER CREATIONBuild a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs. | Other | – |
Primary outcome
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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Derived from this study: PubMed 40990223Benlarbi 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.
- Derived from this study: PubMed 40932389Spagnuolo V, Galli L, Li J, Dunn K, Lagi F, Gagliardini R, Sarmati L, Cattelan AM, Giacomelli A, Santoro MM, Zazzi M, Callebaut C, Castagna A, VanderVeen LA. Teropavimab and zinlirvimab sensitivity in people living with multidrug-resistant HIV-1: data from the PRESTIGIO Registry. Microbiol Spectr. 2025 Oct 7;13(10):e0277724. doi: 10.1128/spectrum.02777-24. Epub 2025 Sep 11.
- Derived from this study: PubMed 39206886Clemente 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.
- Derived from this study: PubMed 38341206Clemente 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.
- Derived from this study: PubMed 34999223Rusconi 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.
- REGISTER E-CRF WEBSITELink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared in scientific conferences and meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonella Castagna principal investigator
san raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Multi-Antiviral Resistance, run by Castagna Antonella at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella Castagna (0226437934, castagna.antonella1@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: each 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098315, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.