iPrEx OLE Study: Gladstone Institute

After the success of iPrEx, DF/Net continued working with the Gladstone Institute, providing the data management for iPrEx OLE. iPrEx OLE (Open Label Extension) is a continuation of the iPrEx study designed to provide additional information about the safety of PrEP and the behavior of people taking PrEP over a longer term. It is hoped that participants’ knowledge that Truvada PrEP provides some protection against HIV infection, and the fact that all HIV-negative participants in iPrEx OLE know that they are receiving Truvada PrEP and not a placebo, will lead to increased use of the study drug by participants in iPrEx OLE, and increased protection against HIV infection.

iPrEx OLE started enrollment on June 13th, 2011 at the San Francisco Department of Public Health and closed enrollment in July of 2012 at Investigaciones Medicas en Salud in Lima, Peru. A total of 1,770 participants enrolled in iPrEx OLE at 11 sites in six countries. Results from this open label extension phase of the study are expected by the first quarter of 2014.

The 11 participating sites for this study are located in Peru, Ecuador, Brazil, the United States, South Africa and Thailand.

For more information on iPrEx OLE, please refer to their web site at:

http://www.iprexole.com/index.html