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Active Not Recruiting
NCT05663580
Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
Conditions: HIV Infections
Sex: All
Ages: 18 Years – N/A
Enrollment: 1500
Sponsor: Castagna Antonella
Location: Italy
Summary
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
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT05663580). StuddyBuddy aggregates publicly available trial information.