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Taking people in ItalyPhase 4

Studies whether early HIV treatment followed by a pause predicts later virus control

Tests markers in adults with HIV treated early, who then pause treatment.

Key facts

Who runs it
Ospedale San Raffaele S.r.l.
Where
Milan, ItalySee the site
Registry title
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
Status
Recruiting
Phase
Phase 4
People taking part
100 people, planned
Started
27 Apr 2022
Planned end
30 Jun 2025
Type of study
Interventional
Record updated
15 July 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with HIV-1 who started antiretroviral therapy (ART) very early, during primary infection. They will pause ART so researchers can study markers that predict control of the virus.

Age
18-60 years in the inclusion criteria (the registry lists 18 to 64 years).
Sex
Men and women.
Disease stage
HIV-1 infection treated with ART started during primary HIV infection (Fiebig stage). No new AIDS-defining diagnosis or progression of HIV-related disease.
Earlier treatment
ART must have been started during primary HIV infection. Plasma HIV-RNA below 50 copies/ml for at least 24 months. Able to keep taking an effective ART regimen during the study.
Biomarker or test result
Plasma HIV-RNA below 50 copies/ml for at least 24 months. CD4+ T cell count above 350 cells/mm3 at the last routine follow-up visit.

Main reasons for not taking part

  • HIV-2 infection
  • Pregnancy
  • History of systemic cancer (such as Kaposi's sarcoma or lymphoma) or of an AIDS-defining illness
  • Active or chronic hepatitis B or hepatitis C infection, or syphilis
  • Positive nose-throat swab for SARS-CoV-2 (Step 2 only)

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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 Italy

  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Studies whether early HIV treatment followed by a pause predicts later virus controlGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2024-515419-24-00, who can take part
Record updated
15 July 2024