SHIVAProject ID: 503162
Selection and development of Microbicides for mucosal use to prevent sexual HIV transmission / acquisition.
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.
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