iPrEx OLE (OLE stands for 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 Frnacico Department of Public Health in California, USA and closed enrollment in July 2012 at Investigaciones Medicas en Salud in Lima, Peru. iPrEx OLE enrolled 1770 participantes at 11 sites in six countries. Of all participants enrolled in iPrEx OLE, 1,129 (63.8%) chose the “on-PrEP” track and 473 (26.7%) elected to be “off-PrEP”. A small proportion of HIV negative enrollees (3.1%) were “delayed PrEP” meaning that they were willing to be “on-PrEP” but because of any reason the site has deferred enrollment on that track. There are 168 (9.5%) seropositive participants enrolled in the open label extension. Results from this open label extension phase of the study are expected by the first quarter of 2014.
iPrEx OLE will take place at 11 sites in Peru, Ecuador, Brazil, the United States, South Africa and Thailand. Click here for additional information on the iPrEx OLE study sites.
Click the map to see sites.
|Rio de Janeiro|