Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
Recruiting now
Conditions studied: HIV Infections
In brief
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
Key facts
- Study ID
- NCT05663580
- Run by
- Castagna Antonella
- People needed
- 1500
- Starts
- 2022-07-17
- Expected to finish
- 2027-07-17
- Last updated by the study team
- 2025-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Ospedale San Raffaele Scientific Institute — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.