2024-515419-24-00RecruitingPhase 4
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
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 27 Apr 2022
- Lead sponsor
- Ospedale San Raffaele S.r.l.
- Diseases
- HIV
- EU CT number
- 2024-515419-24-00
- EudraCT number
- 2020-006102-23
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Women who are pregnant
- Only Step 2 Naso-pharyngeal swab positive for SARS-CoV-2
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.