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RECRUITING
NCT05663580

Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy

Sponsor: Castagna Antonella

View on ClinicalTrials.gov

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

DRUG

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