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The Italian Cohort (ITACO) and the Analytical Antiretroviral Treatment Interruption Italian Cohort (ITACO-ATI) study guided by molecular HIV-1 reservoir profiling

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518694-33-00
Acronym
ITACO_2780_OPBG_2022
Enrollment
61
Registered
2025-01-31
Start date
2023-08-08
Completion date
Unknown
Last updated
2025-07-24

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

Conditions

perinatally HIV infection

Brief summary

1. ITACO cohort: Proportion of patients with absence or HIV intact proviruses, isolated from at least 20 million peripheral blood mononuclear cells (PBMCs), located in heterochromatin positions, which include (i) all non-genic positions, (ii) positions in ZNF genes on chromosome 19, which display extensive binding to heterochromatin proteins and associated with repressive histone modifications (PredictHIV negative) 2. ITACO-ATI cohort: Proportion of patients “PredictHIV negative” who underwent A

Detailed description

1. ITACO cohort: • Proportion of patients with virus inducibility (TILDA assay) in the whole cohort and with distinct latency reversal agents (LRAs) in vitro • Proportion of patients with GALT with absence of intact HIV provirus • Adverse events and serious adverse events 2. ITACO-ATI cohort: • Time from ART discontinuation (start of ATI) to HIV RNA rebound to ≥ 1,000 copies/mL. • Time from ART discontinuation to meeting criteria for ART re-initiation. • Proteomic and In Vitro Gene Expre

Interventions

Sponsors

Ospedale Pediatrico Bambino Gesu
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
1. ITACO cohort: Proportion of patients with absence or HIV intact proviruses, isolated from at least 20 million peripheral blood mononuclear cells (PBMCs), located in heterochromatin positions, which include (i) all non-genic positions, (ii) positions in ZNF genes on chromosome 19, which display extensive binding to heterochromatin proteins and associated with repressive histone modifications (PredictHIV negative) 2. ITACO-ATI cohort: Proportion of patients “PredictHIV negative” who underwent A

Secondary

MeasureTime frame
1. ITACO cohort: • Proportion of patients with virus inducibility (TILDA assay) in the whole cohort and with distinct latency reversal agents (LRAs) in vitro • Proportion of patients with GALT with absence of intact HIV provirus • Adverse events and serious adverse events 2. ITACO-ATI cohort: • Time from ART discontinuation (start of ATI) to HIV RNA rebound to ≥ 1,000 copies/mL. • Time from ART discontinuation to meeting criteria for ART re-initiation. • Proteomic and In Vitro Gene Expre

Countries

Italy

Outcome results

None listed

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