SYF6627b90d63e64a49b36239f8ac0ce943

RecruitingPhase 4

Study of the genetic, viral and immune response characterist...

SYF6627b90d63e64a49b36239f8ac0ce943Registry ID: 2024-515419-24-00|RecruitingPhase 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)

Ospedale San Raffaele S.r.l.

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 25, 2024
Actual (reported)

Conditions

HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection

Outcome Measures

Primary Outcomes (2)

Step 1: To complete the immune-virologic and immune-genetic profiling of volunteers enrolled in the study and perform all the statistical analysis within the time frame proposed (21 months) before the beginning of the MAP cohort recruitment
Step 2: Proportion of participants who controlled viremia counts (<50%) and maintained a stable CD4 T-cell count = 350 cells/μl for all the follow-up (6 months) (no CD4 significant drop)

Interventions

DOLUTEGRAVIR AND RILPIVIRINE Type not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

Male or female, aged 18-60 years
Confirmed HIV-1 seropositive documented
ART commenced during primary HIV infection, as defined by Fiebig stage

Sponsors & Collaborators

Ospedale San Raffaele S.r.l.
Type not reportedlead

Study Sites (1)

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Antonella Castagna0226433473 castagna.antonella1@hsr.it

Central Study Contacts

Antonella Catsagna

0226433473 castagna.antonella1@hsr.it

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

June 25, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-515419-24-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:21:47 UTC

Documents

D1_Protocol_2024-514580-26-00_Redacted

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

E1_IB_JULUCA

Blank document_ not required under directive

L1_ICF_adults_A_Redacted

L1_ICF_genetica_Redacted

L1_ICF_adults_privacy_Redacted

L1_ICF_adults_A-OS_Redacted

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations