MURINE REPRODUCTIVE TOXICITY STUDIES TO EVALUATE POTENTIAL NEURAL TUBE DEFECTS ASSOCIATED WITH DOLUTEGRAVIR

Westat, Inc., Rockville MD

Investigators

Abstract

This study is to obtain preclinical animal toxicology data that addresses the potential of dolutegravir or other integrase stand transfer inhibitor (INST) antiretroviral drugs to produce neural tube defects. Background Neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women infected with human immunodeficiency virus (HIV) who were treated with dolutegravir, and antiretroviral drug of the integrase strand transfer inhibitor (INSTI) class.