Safety, tolerance and antiretroviral activity of dasatinib: a pilot clinical trial in patients with recent HIV-1 infection

Conditions

Asymptomatic patients with recent HIV-1 infection

Brief summary

The primary endpoint of the study is to assess the safety and tolerability of dasatinib with and without antiretroviral therapy using the incidence of AA.

Detailed description

Immunological endpoints: -immune recovery (CD4 subpopulation levels). -inflammatory markers (ultra-sensitive CRP, IL6, TNF alpha) -immune activation (CD4/CD8, CD25, CD69, CD38, HLA-DR+) -bacterial translocation (rsCD163) -levels of NK-mediated cytotoxic activity (NK phenotyping and in vitro replication inhibition tests)., Virological endpoints: -decline in HIV viral load prior to ART initiation (4 weeks of dasatinib monotherapy) -impact on the viral reservoir (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites) -SAMHD1 phosphorylation levels, Senescence endpoints: -Expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.

Related papers

No related papers found yet.

Interventions

DRUGDASATINIB

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is to assess the safety and tolerability of dasatinib with and without antiretroviral therapy using the incidence of AA.	—

Secondary

Measure	Time frame
Immunological endpoints: -immune recovery (CD4 subpopulation levels). -inflammatory markers (ultra-sensitive CRP, IL6, TNF alpha) -immune activation (CD4/CD8, CD25, CD69, CD38, HLA-DR+) -bacterial translocation (rsCD163) -levels of NK-mediated cytotoxic activity (NK phenotyping and in vitro replication inhibition tests)., Virological endpoints: -decline in HIV viral load prior to ART initiation (4 weeks of dasatinib monotherapy) -impact on the viral reservoir (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites) -SAMHD1 phosphorylation levels, Senescence endpoints: -Expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.	—

Measure

Time frame

Immunological endpoints: -immune recovery (CD4 subpopulation levels). -inflammatory markers (ultra-sensitive CRP, IL6, TNF alpha) -immune activation (CD4/CD8, CD25, CD69, CD38, HLA-DR+) -bacterial translocation (rsCD163) -levels of NK-mediated cytotoxic activity (NK phenotyping and in vitro replication inhibition tests)., Virological endpoints: -decline in HIV viral load prior to ART initiation (4 weeks of dasatinib monotherapy) -impact on the viral reservoir (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites) -SAMHD1 phosphorylation levels, Senescence endpoints: -Expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.

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Countries

Spain

Outcome results

None listed