Board Says Stop Experimental Treatment Regimen In HIV Study
An independent Data and Safety Monitoring Board (DSMB) has determined that the experimental, once-daily antiretroviral drug regimen of emtricitabine, atazanavir and didanosine enteric-coated (ddI-EC) is inferior to a standard antiretroviral drug regimen and therefore should be discontinued in an ongoing clinical trial. The National Institute of Allergy and Infectious Diseases (NIAID), the part of the National Institutes of Health that oversees the trial, concurs with this recommendation and has stopped this component of the study.
This development arose from the DSMB's recent review of safety and efficacy data from a Phase IV clinical trial sponsored by NIAID. The trial is examining whether certain regimens of antiretrovirals taken once a day are at least as good as a standard antiretroviral regimen containing a drug combination taken twice a day. The study involves 1,571 HIV-infected volunteers on four continents who were randomly assigned to take one of three drug regimens: