Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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NIAID Online Update - May 27, 2008
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:
The DSMB found conclusive evidence that the second regimen, emtricitabine + atazanavir + ddI-EC, is inferior to the control regimen primarily because it is less effective at controlling HIV. Based on this finding, the decision has been made to discontinue the emtricitabine + atazanavir + ddI-EC component of the study. All study participants are being notified of the development.
For more information on this announcement, go to:
http://www3.niaid.nih.gov/news/newsreleases/2008/ACTG_5175.htm.
For more information on HIV treatment guidelines, please go to:
http://www.aidsinfo.nih.gov/ and click on "Guidelines."
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Published 2008 - National Institute of Allergy and Infectious Diseases . All material contained in this report is in the public domain and may be used and reprinted without special permission; citation to source, however, is appreciated.
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