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IPM’s staff presented in written and oral form a full update of the progress of the internal and external product development programs ongoing at IPM.
SAB Executive Committee recommendations and advice:
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IPM should continue to pursue access to compounds that are active at various stages of the viral infection process, i.e., blocking entry of virus into the human cell by either directly inhibiting the virus or blocking the cell receptor, or impeding replication or integration of virus once in the cell. |
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The Executive Committee agreed that proving that a microbicide product with an antiviral drug(s) is efficacious is of the highest priority. Potential risks, including resistance, will be studied rigorously in parallel with any efficacy study. |
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The Executive Committee was supportive of pursuing the development of and collecting more data on dapivirine as a single agent, in both vaginal ring and gel formulations, and exploring other delivering methods, e.g., vaginal tablets and films. |
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The Executive Committee agreed with IPM’s strategy to design combination candidate microbicides with two or more active ingredients that have different mechanisms of action. |
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IPM is encouraged to pilot any novel trial design, such as directly observed therapy (DOT, adapted for prevention) of the gel, in advance of implementing such a design for Phase III. |
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IPM is encouraged to investigate the feasibility of a community-based trial design for a Phase III efficacy trial, continue to conduct incidence studies and develop novel compliance monitoring technologies. |
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