Registry of HIV-1 Patients with Drug Resistance
Registro Italiano Dei Pazienti Con Infezione da HIV-1 Con RESistenza Agli Inibitori Della Trascrittasi Inversa, Dell'InteGrasI e Della PrOteasi Virale (PRESTIGIO)
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT04098315 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 14 years with HIV-1 infection and documented resistance to all four classes of antiretroviral drugs.
Not a fit: Patients without documented resistance to antiretroviral drugs or those under 14 years of age may not benefit from this registry.
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 performed: Other studies have shown success in monitoring drug resistance in HIV-1 patients, indicating that this approach is supported by previous findings.
Eligibility criteria
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 this trial is running
Milan, MI
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.