Study of the genetic, viral and immune response characteristics of a group of patients infected with the AIDS virus treated early and then subjected to suspension of antiretroviral therapy to define biological markers predicting the control of virus replication after pharmacological treatment
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Olaszország
- Ospedale San Raffaele S.r.l.Milan, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedale San Raffaele S.r.l.
- Trial code
- EU 2024-515419-24-00
- Record updated
- 2024. július 15.
- Original description
Step 1: Investigate a set of immune-genetic and viroimmunologic biomarkers that might be useful to individuate PTC Step 2: Validate the Predictive Algorithms of PTCRead full original descriptionShow less
Study of a novel combination of immunovirologic and genetic parameters in early-treated HIV-1 patients undergone to antiretroviral therapy interruption (ATI) aimed at defining an algorithm predictive of post-treatment control (PCT)
Step 1: Investigate a set of immune-genetic and viroimmunologic biomarkers that might be useful to individuate PTC Step 2: Validate the Predictive Algorithms of PTC
Inclusion: Male or female, aged 18-60 years; Confirmed HIV-1 seropositive documented; ART commenced during primary HIV infection, as defined by Fiebig stage; Plasma HIV-RNA < 50 copies/ml for at least 24 months; CD4+ T cell count > 350 cells/mm3 at the last routine follow-up visit; No new AIDS-defining diagnosis or progression of HIV-related disease; Able to adhere to an effective ART regimen for the duration of the study; Willing and able to give written informed consent for participation in the study.
Exclusion: Confirmed HIV-2 seropositive; History of systemic cancer, such as Kaposi’s sarcoma and lymphoma, or other virusassociated malignancies and/or history of AIDS-defining illness according to Centers for Disease Control and Prevention criteria; Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both active and chronic hepatitis C virus infection, with detectable virus RNA, and syphilis; Women who are pregnant; Only Step 2 Naso-pharyngeal swab positive for SARS-CoV-2.