This Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) brings together a network of investigators representing two companies and five academic institutions to perform multidisciplinary preclinical and exploratory clinical studies with the goal of advancing a safe, novel trivalent topical microbicide, mapp66. This microbicide formulation is comprised of three monoclonal antibodies (Mabs), produced by genetic engineering in Nicotiana benthamiana (-N), that are designed to block distinct mechanisms of HIV sexual transmission. Success of this IPCP-HTM will rely upon an Administrative Core (Core A) that will provide scientific and administrative leadership in coordinating the six Scientific Projects, and the multiple sites that make up this IPCP-HTM program. The Administrative Core will also coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones.
The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, Core A will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. Core A will also convene a Scientific Advisory Panel (SAP) to review the program in years 3 and 5. Core A will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. Specifically, Core A will be responsible for the reagent/research material and data management and sharing plan, for monitoring milestone achievements and coordinating biostatistical services, if required by the individual projects/cores.
This Integrated Preclinical/Clinical Program for HIV Topical Microbicides will develop a combination monoclonal antibody product for use as a vaginal microbicide to protect against sexually transmitted infections, including HIV/AIDS and HSV/genital herpes.
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