Observational study of HIV-positive individuals receiving long-acting antiretroviral therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ospedale San Raffaele Scientific Institute
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Antonella Castagna, Professor
• Email: castagna.antonella1@hsr.it
• Phone: + 39 0226437934

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Camino HIV Prevention and Care Study

  This study tests a combined legal and peer-support program to help Latin American adults in DC and the Bay Area improve HIV testing, PrEP use, and care engagement.

  Recruiting American University · Berkeley, California and 1 other locations · NCT07834853

• VH4367310 in healthy adults: testing single increasing doses for safety and how it behaves in the body

  This study tests a single rising dose of VH4367310, a cabotegravir prodrug, to see how it behaves in the body and how safe and tolerable it is in healthy adults aged 18 to 55.

  Recruiting at 2 sites Phase 1 ViiV Healthcare · Glendale, California and 1 other locations · NCT07818915

• Online cohort of sexual and gender minorities testing digital support to boost PrEP and ART use

  In Brazil, sexually and gender diverse adults are being followed online to see if weekly WhatsApp reminders help people stick to PrEP or ART.

  Recruiting Oswaldo Cruz Foundation · Rio de Janeiro, Rio de Janeiro · NCT07772791

• Metabolic Liver Disease in People Newly Diagnosed with HIV

  This study tests whether HIV-infected adults who are starting ART are more likely to develop MASLD and related liver issues than HIV-negative adults over five years.

  Recruiting at 11 sites Guven Health Group · Ankara, Ankara and 10 other locations · NCT07737340

• Screen2Prevent: HIV screening for teens and young adults in emergency departments

  The study tests three ways of offering HIV screening to people aged 14–24 in emergency departments to see if it helps link them to PrEP or HIV treatment using digital health tools.

  Recruiting at 5 sites Westat · Tampa, Florida and 4 other locations · NCT07728123

• Long-acting LEN/TAB/ZAB vs CAB/RPV in adults with HIV-1 who are virologically suppressed on daily ART

  This study tests whether switching to a weekly-plus long-acting injectable regimen of lenacapavir, teropavimab, and zinlirvimab works as well as a two-drug injectable regimen of cabotegravir and rilpivirine for adults with HIV-1 who already have undetectable virus on daily treatment.

  Recruiting at 19 sites Phase 3 Gilead Sciences · San Francisco, California and 18 other locations · NCT07682961

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.