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Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
Sponsor: Castagna Antonella
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
Official title: Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy (SCohoLART)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2022-07-17
Completion Date
2027-07-17
Last Updated
2025-05-07
Healthy Volunteers
No
Conditions
Interventions
Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL
Initial administration of two separate intramuscolar injection of cabotegravir 400mg/3mL and rilpivirine 600mg/3mL in opposite gluteal muscles, repeated one month later and then every two months.
Locations (1)
Ospedale San Raffaele Scientific Institute
Milan, Italy