AIDSWEEKLY Plus, Monday, 20 October 1997
Daniel J. DeNoon, Senior Editor
Enrollment has been halted in a clinical trial of passive immunoprophylaxis of mother-to-child HIV transmission.
Early results from the trial showed that the study lacked power to detect whether addition of hyperimmune HIV immunoglobulin (HIVIG) improved this effect. Trial cessation was not due to any safety problems with HIVIG.
But the trial (Pediatric AIDS Clinical Trials Groups (PACTG) protocol 185) was not a total loss: it provided new evidence that zidovudine (AZT) can lower rates of vertical HIV transmission.
"These results not only confirm AZT efficacy for reducing perinatal transmission, as seen in PACTG 076, but extend this efficacy to women with more advanced disease and prior AZT use," reported Lyne Mofenson of the U.S. National Institutes of Health. "The results provide added support to existing recommendations for universal prenatal HIV testing, offering antenatal AZT to all infected pregnant women for the purpose of reducing transmission, or as a component of whatever regimen they receive for their own health, and that intrapartum/newborn AZT should be a component of that therapy."
Mofenson reported the findings in an address to the American Society for Microbiology's 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held September 28 to October 1, 1997, in Toronto, Ontario, Canada.
The study randomized women to receive HIVIG or standard intravenous immunoglobulin (IVIG) every month beginning at 20 to 30 weeks gestation; a single dose was given to newborns within 24 hours of birth. All trial participants received recommended neonatal/intrapartum AZT.
The first interim data analysis took place after evaluation of 379 infants. The overall rate of HIV transmission was 4.8 percent, which increased with lower CD4 count at study entry.
Transmission was not significantly different among women who received HIVIG or IVIG.
"Since the conditional power to detect a 50 percent treatment effect with the planned 800 subjects was only 29 percent, enrollment was halted," Mofenson said.
971020
AW971001
Copyright © 1997 - Charles Henderson, Publisher. All rights Reserved. Permission to reproduce granted to AEGIS by Charles W. Henderson. Authorization to reproduce for personal use granted granted by C. W. Henderson, Publisher, provided that the fee of US$4.50 per copy, per page is paid directly to the Copyright Clearance Center, 27 Congress Street, Salem, Massachusetts 01970, USA.
Published by Charles Henderson, Publisher. Editorial & Publishing Office: P.O. Box 5528, Atlanta, GA 30307-0528 / Telephone: (800) 633-4931; Subscription Office: P.O. Box 830409, Birmingham, AL 35283-0409 / FAX: (205) 995-1588 http://www.newsfile.com
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1997. 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 ©1990, 2000. AEGiS & the Sisters of Saint Elizabeth of Hungary. 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 ÆGIS, or the party credited as the provider of the content.