Objective The main objective of this 4 years IP is the development, up to clinical phase I, of a specific HIV microbicide for the prevention of sexual transmission/acquisition of HIV, based on the interruption of viral replication at the mucosal level. Some members of a new class of non-nucleoside reverse transcriptase inhibitors (NNRTIs), the DABOs, proved capable of irreversibly knocking out HIV-1 replication. This property correlates with their ability to tightly bind to the HIV-1 Reverse Transcriptase. The lead compound of these series of tight binding NNRTIs is MC1220. The organisation of this project comprises 3 discovery chemistry teams combined with a 3D modelling team who will investigate other compounds for back up and combination purposes.The global preclinical and pharmaceutical workflow is organized to permit very rapid access to formulation screening and challenge efficacy model in the macaque in 2 centres, 1 in Europe, 1 in Africa. Finally the clinical phase I trial will involve HIV medical teams very implicated towards development of clinical trialand treatment networks in Africa. The work programme is organised in i) the research engine for validation of concept of MC1220 as a microbicide in in-vitro assays & for the design / synthesis optimisation of DABOs & uracil based NNRTIs ii) for pharmaceutical and preclinical development of candidate lead compound, iii) formulation screening and challenge efficacy model for proof of principle in a validate primate model for vaginal RT-SHIV challenge and iv) studies and tasks directly aimed at conducting Phase I tolerability studies in women. 11 partners, from academy to industry will contribute to the project & focus both on respect of timing and achievement of expected objectives, as well as to widespread scientific results and economical benefits to achieve all scientific andregulatory requirements to go to phase II clinical trial programmes within EDCTP or Alliance for microbicide for example. Fields of science natural sciencesbiological sciencesmicrobiologyvirologymedical and health scienceshealth sciencesinfectious diseasesRNA virusesHIV Keywords HIV animal models clinical trial women drug development microbicide mucosal Programme(s) FP6-LIFESCIHEALTH - Life sciences, genomics and biotechnology for health: Thematic Priority 1 under the Focusing and Integrating Community Research programme 2002-2006. Topic(s) LSH-2002-2.3.0-2 - HIV microbicides Call for proposal FP6-2002-LIFESCIHEALTH See other projects for this call Funding Scheme IP - Integrated Project Coordinator UNIVERSITA' DEGLI STUDI DI CAGLIARI EU contribution No data Address Cittadella Univesitaria, SS 554 km 4,500 MONSERRATO (CA) Italy See on map Links Website Opens in new window Total cost No data Participants (10) Sort alphabetically Sort by EU Contribution Expand all Collapse all UNIVERSITA DEGLI STUDI DI ROMA "LA SAPIENZA" Italy EU contribution No data Address P. Le Aldo Moro, 5 Box36 Roma62 ROMA See on map Links Website Opens in new window Total cost No data UNIVERSITY OF SOUTHERN DENMARK Denmark EU contribution No data Address 55 Campusvej ODENSE M See on map Links Website Opens in new window Total cost No data UNIVERSITE DE LA MEDITERRANEE-CNRS-AFMB France EU contribution No data Address 58, Bd CHarles Livon, Jardin du Pharo MARSEILLE See on map Links Website Opens in new window Total cost No data LABORATOIRES IDENIX France EU contribution No data Address 170 Rue Leon BLUM MONTPELLIER See on map Links Website Opens in new window Total cost No data UNIVERSITY OF PATRAS Greece EU contribution No data Address University Campus RIO-ACHAIA See on map Links Website Opens in new window Total cost No data DEUTSCHES PRIMATENZENTRUM GMBH Germany EU contribution No data Address Kellnerweg 4 GOETTINGEN See on map Links Website Opens in new window Total cost No data CENTRE INTERNATIONAL DE RECHERCHES MEDICALES DE FRANCEVILLE Gabon EU contribution No data Address 769 FRANCEVILLE See on map Total cost No data UNIVERSITA DI MILANO Italy EU contribution No data Address Via Festa del Perdono, 7 MILANO See on map Links Website Opens in new window Total cost No data INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT France EU contribution No data Address 209 rue Lafayette PARIS See on map Total cost No data ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS France EU contribution No data Address 3 avenue Victoria PARIS See on map Links Website Opens in new window Total cost No data