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

Recruitingn/aAges 18 Years - anyAllCastagna Antonella
NCT05663580 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL
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Where

1 site
Ospedale San Raffaele Scientific Institute
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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