Preparing for access to PRO 2000 microbicide
Report of a meeting (27–28 May 2009, London, United Kingdom)
Since this report was prepared, the results of the MDP 301 study were announced on 14 December 2009 and published in The Lanceton 20 September 2010. (http://dx.doi.org/10.1016/S0140-6736(10)61086-0). The study showed no benefit of 0.5% PRO2000 in reducing the risk of HIV infection. All further development and investment in the product has ceased.
This report summarizes key elements of the meeting discussions: existing data and analysis plans from both the Microbicide Trials Network (MTN) and Microbicides Development Programme (MDP), and priorities for additional clinical research; ownership and licensing; cost; manufacturing; regulatory review; policy and programmes; strategic communications and messaging; and next steps. A chart and timeline summarizing the agreed action plan, roles and responsibilities, and timeframe are attached