NCT05663580 Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
| NCT ID | NCT05663580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Castagna Antonella |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2022-07-17 |
| Primary Completion | 2024-07-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2022-07-17 with a primary completion date of 2024-07-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05663580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05663580 currently recruiting?
Yes, NCT05663580 is actively recruiting participants. Contact the research team at castagna.antonella1@hsr.it for enrollment information.
Where is the NCT05663580 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05663580 clinical trial?
NCT05663580 is sponsored by Castagna Antonella. The trial plans to enroll 1,500 participants.
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