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
- Conditions
- HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infectionTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-515419-24-00
- Lead Sponsor
- Ospedale San Raffaele S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
Confirmed HIV-2 seropositive, Women who are pregnant, 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, Only Step 2 Naso-pharyngeal swab positive for SARS-CoV-2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method