About

Vaxxit is a start-up company created to bring to market the recombinant HIV Tat immunotherapy (rTAT) developed by the National Center for HIV/AIDS Research (CNAIDS) in Rome, Italy). The recombinant TAT has been tested in humans in 3 phase I studies (2 preventive and 1 therapeutic) and in 2 phase II therapeutic trials in Italy (8 years) and in South Africa (3 years) that confirmed its efficacy in intensifying antiretroviral therapy with a robust reconstitution of the immune system, higher than that obtained with drugs alone and highest in volunteers with the lowest numbers at the start of the studies who were responding poorly to therapy (“immunological poor responders”) because started late, (40% of the world HIV population). The phase II studies not only confirmed a robust increase of CD4+ T cells and of CD4+/CD8+ T cells ratio, but more importantly showed in the 8-year Italian study that rTAT drastically accelerates (by 4-7 times) the reduction of the virus reservoirs as compared to therapy alone (Sgadari C et al., Frontiers in Immunology, 2019), characteristics also present in rare HIV patients called "post-treatment controllers" that are capable of controlling the reactivation of the virus after stopping therapy. It is conceivable, therefore, that rTAT could have increased these capability in treated volunteers, an hypothesis that will be assessed in a phase IIb study of programmed and controlled therapy interruption (in planning) that will enrol volunteers of the phase II study in Italy (ISS T-002 rTAT-treated and OBS T-002 controls). The clinical protocol provides for resumption of therapy on the basis of specific immunological and virological criteria and the concerned volunteers will be followed until complete suppression of the virus, testing, if necessary, for drug resistance. If the initial hypothesis is confirmed, the study will open new perspectives for the treatment and eradication of HIV.