NCT04098315Recruiting
Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 16 Sept 2019
- Start date
- 14 Dec 2017
- Primary completion date
- 31 Mar 2020
- Lead sponsor
- Castagna Antonella
- Diseases
- HIV
- NCT number
- NCT04098315
What you commit to
- Study type: Observational
- Planned participants: 300
- From 14 Dec 2017 to the primary completion date, 31 Mar 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- none
Who the study is looking for
- 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.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.