August 4, 2009

On July 27th, 2009, the Data and Safety Monitoring Board (DSMB) conducted a scheduled review of the CAPRISA 004 Tenofovir Gel Phase IIb trial and recommended that the study continue, and furthermore, congratulated the study team on trial conduct.  

"We're very pleased that the trial is continuing as planned and we are hopeful that we will have final results that will move our collective efforts forward in terms of finding a safe and effective microbicide," said Dr. Henry Gabelnick, Executive Director of CONRAD.   

This microbicide trial, conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), is assessing the safety and effectiveness of 1% tenofovir gel to prevent HIV infection in 900 women in South Africa.  Tenofovir is an antiretroviral that prevents HIV from reproducing itself inside human cells. The DSMB regularly reviews interim data of trials to assess continued safety of a product as well as other information, such as number of pregnancies and adherence.

The CAPRISA 004 study is a collaborative effort between CAPRISA at the University of KwaZulu-Natal in Durban, South Africa, Family Health International, and CONRAD, who holds the license for tenofovir gel. It is funded by USAID and the South African Department of Science and Technology through LIFElab in South Africa.

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