Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
 |
AIDS TREATMENT NEWS Issue #304, October 2, 1998
John S. James
Here is the rapidly-changing information on this program, as of September 30 when this issue went to press.
There are three different open-label protocols in the expanded-access program:
Protocol 30010 is for patients who either had viral rebound or were intolerant on a currently-approved protease inhibitor therapy. This protocol is open to both adults and children (ages 4 and above).
Protocol 30011 is for those who are intolerant to their current protease-inhibitor therapy; they can be changed to a specific amprenavir-plus-abacavir protocol, or the physician can choose a dual-protease-inhibitor arm. In order to qualify for this option, they must not have taken abacavir previously for longer than eight weeks. This protocol is open to adults and adolescents (age 13 and above).
Protocol 30012 is an open-label clinical trial to determine the effect of amprenavir on lipid metabolism (hyperlipidemia and lipodystrophy) in subjects experiencing these adverse effects and who are not failing current antiretroviral therapy. It is open to adults and adolescents.
Also, when physicians call, they may be referred to ACTG protocols (398 and 400) with amprenavir treatment arms, in case they could send their patient to a local ACTG site. Also, physicians with pediatric patients may be referred to a Glaxo Wellcome phase III pediatric trial (for patients not previously treated with protease inhibitors). This referral will be a suggestion, not a requirement.
"Regardless of which option physicians and patients opt for, patients need to have received prior treatment with at least one protease inhibitor in addition to fulfilling other standard criteria. Patients will also be strongly encouraged to start at least one other anti-HIV agent that they have not previously used." (Quoted from press statements issued jointly by the two companies).
Over 700 patients have received amprenavir so far through clinical trials.
Patients interested in entering this program should have their physician call the Agenerase/Amprenavir Early Access Program, 800-248-9757, 8 a.m. to 6 p.m. Eastern time, Monday through Friday.
981002
ATN30403
Copyright © 1998 - AIDS Treatment News. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. AIDS Treatment News, Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org http://www.aidsnews.org
Subscription Information: Call 800/TREAT-1-2: Businesses, Institutions, Professionals: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1998. 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, 1998. 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. .