Registry of HIV-1 Patients with Drug Resistance
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)
Run by IRCCS San Raffaele · NCT04098315 · Data updated 2026-11-12
This study is tracking people with HIV-1 who have drug resistance to see how different treatments work for them over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | December 14, 2017 |
| Main results expected | March 31, 2020 |
| Study ends | December 31, 2028 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT04098315 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged over 14 years with HIV-1 infection and documented resistance to all four classes of antiretroviral drugs.
✕Probably not a fit
Patients without documented resistance to antiretroviral drugs or those under 14 years of age may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PRESTIGIO Registry is an observational, multicenter initiative that tracks patients with HIV-1 infection who have documented resistance to multiple classes of antiretroviral drugs. This registry aims to evaluate the long-term effectiveness of various antiretroviral regimens, monitor the evolution of drug resistance, and assess clinical outcomes such as mortality and the incidence of opportunistic infections. Data collection will include clinical, laboratory, and treatment characteristics, with participation from infectious disease centers across Italy. The study will continue for at least three years following ethical approval from participating centers.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies for HIV-1 patients with drug resistance, leading to better health outcomes.
How similar studies have gone: Other studies have shown success in monitoring drug resistance in HIV-1 patients, indicating that this approach is supported by previous findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ospedale San Raffaele
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Antonella Castagna — san raffaele
- Study coordinator: Antonella Castagna
- Email: castagna.antonella1@hsr.it
- Phone: 0226437934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.