Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.
18 to 65 years.
Documented asymptomatic HIV-1 infection of 3-12 months duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).
Not having received ART
CD4 T-lymphocyte count> 350 / μl
Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening.
ALT> 2 UNL, glomerular filtration rate <70 mL / 1.73 m2, leukocytes <4000 / mm3, total lymphocyte count <1000 / mm3, platelets <100,000 / mm3 or Hg <12g / dL.
Pregnancy or active breastfeeding
Ongoing or previous pleural effusion
Parallel
Dasatinib
DrugDasatinib monotherapy 70 mg/day, during 16 weeks.
Placebo
DrugPlacebo during 16 weeks.
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
Measured by number of AEs and SAEs
Antiretroviral capacity of dasatinib
Measured by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.
Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
Measured by changes in the viral reservoirs (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites)
Changes in markers of inflammation and immune activation induced by dasatinib administration.
Measured by changes in ultra-sensitive CRP, IL6, TNF alpha and CD4/CD8, CD25, CD69, CD38, HLA-DR+.
Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
Measured by NK phenotyping and in vitro replication inhibition tests.
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Eva Bonfill
Lead sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor institution
