NCT04098315 Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
| NCT ID | NCT04098315 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Castagna Antonella |
| Condition | HIV-1-infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2017-12-14 |
| Primary Completion | 2020-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2017-12-14 with a primary completion date of 2020-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * none
Contact & Investigator
Antonella Castagna
PRINCIPAL INVESTIGATOR
san raffaele
Frequently Asked Questions
Who can join the NCT04098315 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04098315 currently recruiting?
Yes, NCT04098315 is actively recruiting participants. Contact the research team at castagna.antonella1@hsr.it for enrollment information.
Where is the NCT04098315 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04098315 clinical trial?
NCT04098315 is sponsored by Castagna Antonella. The principal investigator is Antonella Castagna at san raffaele. The trial plans to enroll 300 participants.
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