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Safety and Impact of Dasatinib on Viral Persistence and Inflammation in People with HIV under Antiretroviral Treatment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513714-36-01
Acronym
BCN04-DASA
Enrollment
60
Registered
2024-06-28
Start date
2024-06-28
Completion date
Unknown
Last updated
2024-06-28

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

Conditions

Human immunodeficiency virus

Brief summary

· Proportion of participants that develop Grade 3 or 4 treatment-related adverse events or laboratory abnormalities during the study, based on the CTCAE v5.0 grading scale., · Proportion of SAMHD1 phosphorylation in CD4+ T cells upon in-vitro T cell activation at weeks 0, 2, 12, 24, 28, 36 and 48.

Detailed description

Antiviral effect of dasatinib and its durability:Proviral reactivation capacity upon in-vitro T-cell activation, Resistance to HIV infection, Homeostatic proliferation, Immunomodulatory effects, Impact of dasatinib and its durability on: Inflammation and immune activation, HIV-1 reservoir, CD4+ T cell populations, Pharmacokinetics of dasatinib: · Dasatinib concentrations in plasma at weeks 0, 2, 12 and 24.

Interventions

DRUGDasatinib/Teva 50 mg επικαλυμμένα με λεπτό υμένιο δισκία

Sponsors

Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
· Proportion of participants that develop Grade 3 or 4 treatment-related adverse events or laboratory abnormalities during the study, based on the CTCAE v5.0 grading scale., · Proportion of SAMHD1 phosphorylation in CD4+ T cells upon in-vitro T cell activation at weeks 0, 2, 12, 24, 28, 36 and 48.

Secondary

MeasureTime frame
Antiviral effect of dasatinib and its durability:Proviral reactivation capacity upon in-vitro T-cell activation, Resistance to HIV infection, Homeostatic proliferation, Immunomodulatory effects, Impact of dasatinib and its durability on: Inflammation and immune activation, HIV-1 reservoir, CD4+ T cell populations, Pharmacokinetics of dasatinib: · Dasatinib concentrations in plasma at weeks 0, 2, 12 and 24.

Countries

Spain

Outcome results

None listed

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