Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
Recruiting · NCT05663580 · Observational (researchers observe without assigning treatment) · Lead sponsor: Castagna Antonella
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Systematic, continuative collection of clinical and laboratory data on patients followed at lnfectious Diseases Unit of the IRCCS San Raffaele Hospital in Milan, receiving long-acting ART (Phase IV, single-center, prospective, cohort study) PRIMARY ENDOPOINT: Treatment failure over 48 weeks, defined as virological failure (VF) or therapy discontinuation for any reason (TD) SECONDARY ENDPOINTS: Clinical and pharmacological determinants of efficacy, tolerability, toxicity Modifications in risk and incidence of comorbidities Description of drug-resistance in case of VR Efficacy of rescue regimens in case of VF Quality of life and patient's satisfaction
Who can take part
Inclusion criteria
- HIV infection;
- Age \> 18 years;
- HIV-RNA \<50 copies/ml;
- Stable ART;
- Planned start of a long-acting regimen approved by AIFA (initially, cabotegravir and rilpivirine);
- Written informed consent provided.
Exclusion criteria
- \- Any contraindication to the use of one or more long-acting drug, according to the technical sheet of the long-acting drug(s) planned to be started (including pregnancy, current or planned).
Where it is running
1 location listed.
- Ospedale San Raffaele Scientific Institute - Milan, Italy