Clinical trial Recruiting at 1 site Observational Ages 14 and up

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.

More HIV-1-infection trials

Quick facts

Study typeObservational
Ages14 Years and up
SexAll
Enrollment300 (estimated)
SponsorIRCCS San Raffaele
Academic / other
Locations1 site (Milan, MI)
StatusRecruiting
StartedDecember 14, 2017
Main results expectedMarch 31, 2020
Study endsDecember 31, 2028
Registry record updatedMay 7, 2025
Trial IDNCT04098315 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

  • Ospedale San Raffaele
    Milan, Mi, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.