RecruitingNCT05663580

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

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

Sponsor

Castagna Antonella

Enrollment

1,500 participants

Start Date

Jul 17, 2022

Study Type

OBSERVATIONAL

Conditions

HIV Infections

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria1

\- 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).

Interventions

DRUGCabotegravir 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.