At the end of January 2007, the Data Safety and Monitoring Boards (DSMB) of CONRAD met and based on a review of preliminary data, recommended that the Phase III trial of the candidate microbicide Cellulose Sulfate (CS) in Benin, India, Uganda and South Africa be discontinued. Early data suggest that CS may be contributing to an increased risk of HIV infection. Scientists are struggling to figure out exactly what this means given that 11 earlier safety trials had not revealed any safety concerns. Erring on the side of safety, the Family Health International DSMB recommended that the CS trial underway in Nigeria be closed as well, although review of the Nigerian data by that trial’s DSMB found no evidence of increased risk.
The Global Campaign for Microbicides (GCM) and the African Microbicides Advocacy Group (AMAG) have been collecting questions from advocates and seeking answers from site investigators, sponsors, microbicide experts and information publicly available about the trials. Below you will find both a Question and Answer document that summarizes what we have learned so far, as well as a factsheet on scientists evaluate safety of candidate microbicides.
GCM and AMAG are in the process of planning opportunities for advocates to share information and views about the trial closures. If you have questions that are not addressed in these documents, please forward them to email@example.com and we will do our best to track down the answer.