Objective To demonstrate the technical viability of a medical device for accomplishing the selective immunodepletion of HIV virus and HIV antigens from the plasma of HIV infected patients.The medical device consists of a specialized immunoabsorption unit coupled with a standard plasmapheresis apparatus. This type of ex^vivo treatment will not deplete HIV infected cells, but only free HIV virions and HIV antigens/immunocomplexes, therefore clinical benefits are expected only by using the treatment on a regular basis and in combination with other standard HIV therapies. Economical calculation of the cost of treatment session will be performed.The immunoabsorption unit consists of a closed filter system bearing one or more ligands specific for the HIV envelope or for immune complexes, both of which are abundant in HIV infected patients and which contribute to pathogenesis. The immunoabsorption unit will contain recombinant CD4 (CD4 is the natural receptor for HIV) and will deplete both HIV virions and HIV envelope antigens. Another type of immunoabsorption unit produced will contain anti-envelope monoclonai antibodies which, similarly to CD4, directly bind both soluble and virionic envelope antigens.Other ligands will be used as alternative to CD4 and anti-gp120 antibodies. These ligands will be tested in parallel outside of the contract and will be used for manufacturing the immunoabsorption units only if the testing will demonstrate in vitro efficacy. These alternative ligands are anti-HLA antibodies, which recognize virionic HLA moiecules, complement factor C1 q which has a high affinity for polymeric immunoglobulins like those present in antigen/antibody complexes, GNA lectin which has been recently shown to bind with very high affinity HIV gp120.The project is divided into two distinct phases: during the first phase specifications of optimal ligand characteristics for the immunoabsorption unit, and manufacturing and quality control protocols will be set. At the end of the first phase three lots of clinical grade immunoabsorption units will be ready to be tested in patients. The second phase will be a phase 1 clinical trial (safety and determination of treatment frequency) on a limited number of patients. The number of patients enrolled will depend on the types of immunoabsorption units available at the end of the first phase (i.e. CD4, anti-gp120, and other alternative ligands). Fields of science natural sciencesbiological sciencesmicrobiologyvirologymedical and health scienceshealth sciencesinfectious diseasesRNA virusesHIV Programme(s) FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998 Topic(s) 8.2 - Demonstration Call for proposal Data not available Funding Scheme CSC - Cost-sharing contracts Coordinator Centre Intégré de Recherche Bioclinique sur le Sida EU contribution No data Address 185,rue Raymond Losserand 75014 Paris France See on map Total cost No data Participants (7) Sort alphabetically Sort by EU Contribution Expand all Collapse all Fondazione Centro San Raffaele del Monte Tabor Italy EU contribution No data Address Via Stamira d'Ancona 20 20127 Milano See on map Total cost No data Genopoietic SARL France EU contribution No data Address 11,Rue du Tage 75013 Paris/Ile de France See on map Total cost No data Karolinska Institute Sweden EU contribution No data Address 2,Lundagatan 2 105 21 Stockholm See on map Total cost No data Paul-Ehrlich-Institut Germany EU contribution No data Address 51-59,Paul-Ehrlich-Strasse 63225 LANGEN/FRANKFURT See on map Total cost No data Sanitaria Scaligera SpA Italy EU contribution No data Address Via della Consortia 2 37127 Verona See on map Total cost No data St George's Hospital Medical School United Kingdom EU contribution No data Address 83,Cranmer Terrace SW17 ORE TOOTING LONDON See on map Total cost No data Université Pierre et Marie Curie France EU contribution No data Address 11,Rue du Tage 75013 PARIS See on map Total cost No data
