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January 31, 2007
The Data Safety and Monitoring Boards of CONRAD met a few days ago and based on a review of preliminary data, recommended that the Phase III trial of the microbicide candidate, Cellulose Sulphate (CS), in Benin, 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 FHI 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.
Below you will find a joint statement issued by AMAG, GCM and AVAC, and the CONRAD and FHI press releases announcing these decisions. AMAG and GCM are looking at this news carefully to understand what the results mean to advocates and to the field, in order to respond in the most appropriate manner.
Over the next few weeks, we will be looking at ways to make sure that advocates' questions and concerns are heard and addressed with concrete responses. We will also be considering what follow-up activities are needed to address these concerns. Later we will forward a question-and-answer fact sheet about the trials and the findings and we will be sponsoring a number of conference call discussions/briefings for advocates.
Q & A on closure of cellulose sulfate trial (from the Global Campaign for Microbicides)
GCM Safety Brief
Civil Society statement on the trials
CONRAD press release
POLYDEX press release
Family Health International press release
WHO/UNAIDS statement on the trials
International Partnership for Microbicides statement on trials
To keep up to date on this story as it develops and other related AIDS vaccine and prevention research news, subscribe to the Advocates' Network.
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