sexually transmitted diseases

Nevirapine trials controversy

There have recently been a number of media reports that Boeringer-Ingelheim's application to the Food and Drug Authority of the USA for the registration of Nevirapine was withdrawn due to irregularities and deficiencies related to the HIVNet 012 trail in Uganda. (This was the first field study that demonstrated the efficacy of NVP to reduce mother to child transmission). The irregularities and deficiencies relate to documentation procedures and DO NOT relate to any of the substantive findings on both the efficacy and safety of NVP. Included in the full text are press statements made by WHO/UNAIDS, CDC, Boeringer Ingelheim, National Institute of Health (USA) and the Elizabeth Glaser Foundation. They all essentially state that NVP still works and is still safe.