Observational study of HIV-positive individuals receiving long-acting antiretroviral therapy
Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy (SCohoLART)
This study is looking at how well long-acting HIV medications work for people living with HIV and how they affect their overall health and quality of life over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05663580 on ClinicalTrials.gov |
What this trial studies
This study involves the systematic collection of clinical and laboratory data from HIV-positive patients at the Infectious Diseases Unit of the IRCCS San Raffaele Hospital in Milan who are being treated with long-acting antiretroviral therapy, specifically cabotegravir and rilpivirine. The primary endpoint is to assess treatment failure over 48 weeks, while secondary endpoints include evaluating clinical and pharmacological factors affecting efficacy, tolerability, and quality of life. Patients will be monitored according to standard care protocols, with follow-up visits and laboratory tests conducted every six months. The study aims to gather comprehensive data to improve treatment strategies for HIV-infected individuals on long-acting ART.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals over 18 years old, with a stable ART regimen and an HIV-RNA level of less than 50 copies/ml.
Not a fit: Patients who are pregnant or have contraindications to the long-acting drugs being studied will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and treatment outcomes for HIV-positive patients by providing insights into the efficacy and tolerability of long-acting antiretroviral therapies.
How similar studies have performed: Other studies have shown promising results with long-acting antiretroviral therapies, indicating that this approach is gaining traction in HIV treatment.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Milan
- Ospedale San Raffaele Scientific Institute — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Antonella Castagna, Professor
- Email: castagna.antonella1@hsr.it
- Phone: + 39 0226437934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.