Associated Press - December 14, 2004

Smith's original version:

"Acceptable or required timeframes for reporting SAEs (severe adverse events) and deaths were not followed."

"The safety reporting quality for the HIVNET012 study does not meet levels expected in perinatal trials sponsored by DAIDS (NIH Division of AIDS)."

"The supervision or monitoring of the willing and capable Ugandan site personnel in all aspects of safety, including subject information regarding treatment risks, verification of eligibility criteria for mothers and infants as well as safety reporting does not appear to have been in place and raises concerns about the study conduct."

"Safety reporting did not follow DAIDS reporting requirements during the conduct of HIVNET012. Safety conclusions from this trial should be very conservative."

"Site records for safety monitoring and subject visits were of poor quality and make safety statements very difficult from the perspective of a review process."

"Monitoring during the trial for safety and clinical trial management was not in evidence."

Tramont's final version:

"There was some concern expressed by one of the American physician monitors about the adequacy of standards of clinical care in Uganda."

"During the full review of 80 mother-infant charts, the reporting of AEs (adverse events) was found to be generally complete. The discrepancies that were found between the database and the source documentation were due to some missing information in the adverse event report."

"The remonitoring of review process undertaken by the safety review panel has shown that there was a consistent attempt throughout the study to document AEs and SAEs as evidenced by the large numbers of such reports ... and the small numbers of missed events in the remonitoring process."

"HIVNET 012 has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission of HIV infections. Although discrepancies were found in the database and some unreported AEs were discovered during the remonitoring process, these were not clinically important in determining the safety profile."

041214
AP041240

Copyright © 2004 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .