Actively Recruiting

Age: 18Years +
All Genders
NCT05663580

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

Led by Castagna Antonella · Updated on 2025-05-07

1500

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV infection
  • Age over 18 years
  • HIV-RNA less than 50 copies/ml
  • Stable antiretroviral therapy
  • Planned start of a long-acting regimen approved by AIFA (initially cabotegravir and rilpivirine)
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Any contraindication to the use of one or more long-acting drugs according to the drug's technical sheet (including pregnancy, current or planned)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ospedale San Raffaele Scientific Institute

Milan, Italy, 20127

Actively Recruiting

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Research Team

A

Antonella Castagna, Professor

CONTACT

E

Elisabetta Carini

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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