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

NCT05663580 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-05-07

No results posted yet for this study

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

Conditions

  • HIV Infections

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.

Sponsors & Collaborators

  • Castagna Antonella

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-17
Primary Completion
2024-07-17
Completion
2027-07-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663580 on ClinicalTrials.gov