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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)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515419-24-00
Enrollment
100
Registered
2024-07-15
Start date
2022-04-27
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

DRUGDOLUTEGRAVIR AND RILPIVIRINE

Sponsors

Ospedale San Raffaele S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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)

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026