Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 28 Aug 95
The special "expanded access" program, approved by the Food and Drug Administration, represents the broadest use of thalidomide ever allowed in this country.
Celgene Corp. is conducting clinical trials to see if its brand of thalidomide, called Synovir, counteracts the wasting, or severe weight loss, that plagues 150,000 AIDS patients.
There is little proof yet that it works. But two other wasting therapies are only moderately effective, so some patients who don't meet the strict criteria for the Synovir clinical studies have demanded the drug.
The FDA is allowing Celgene to give Synovir experimentally to any AIDS patient who is wasting and also has infections, malignancies, has failed other treatments or is near death.
Patients will be given one of two doses -- 50 milligrams or 200 milligrams -- and then will be tracked for weight gain.
Thalidomide, widely used abroad in the 1950s to fight morning sickness, was never approved here because the FDA caught early word of its risks and delayed the drug pending investigation.
Now thalidomide is being studied to treat several illnesses. The FDA allows special limited access to thalidomide for AIDS patients with a painful type of mouth ulcer and for leprosy, but the Celgene program will allow broader use.
Because of the birth defect risk, women must sign an agreement to use two forms of birth control, both a barrier method and a hormone, to participate. ------
EDITOR'S NOTE -- To participate, call 800-896-6766 beginning at 8 a.m. EDT Wednesday.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
950828
AP950820
Copyright © 1995 - 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, Pacific Life Foundation, and donations from users like you.
Always watch for outdated information. This article first appeared in 1995. 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, 1995. 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. .