Statement on IDMC review of MDP301 trial data on 12th March 2007
The Independent Data Monitoring Committee (IDMC) for the Microbicides
Development Programme (MDP) met on 12th March 2007 to examine the data
collected to date on the MDP301 trial of the candidate microbicide PRO2000, and
updated since its last meeting on 10th January 2007. This additional review was
prompted by the recent early closure of a separate trial of a different candidate
microbicide, cellulose sulphate, and included an assessment of data from that trial.
After reviewing all the available data, the IDMC reported that the MDP301 trial
should continue according to the protocol. The IDMC congratulated the investigators
on progress to date. The MDP Trial Steering Committee (TSC) met on 13th March
2007 and accepted the recommendation of the IDMC.
The IDMC will continue to monitor the trial carefully and will meet again in four
months time. Safety of the participants continues to be of paramount importance.