AIDSWEEKLY Plus; Monday, May 17, 2004
Staff Medical Writers

The trial is being conducted by researchers at Georgetown University.

The study's enrollment at the outset is limited to 10 patients who are in virologic failure and no longer able to benefit from the administration of Highly Active Anti-Retroviral Therapy (HAART). It is estimated that more than 50% of AIDS patients ultimately become non-responsive to such drugs during the course of their treatment.

The Georgetown University researchers will initially use an inhibitor that targets TNF-α, a pro-inflammatory cytokine, one of several cytokines that is overproduced in many chronic immune diseases, resulting in severe disturbance of the body's immune system. The new phase I study is intended to test the safety and possibly show a clinical effect of this inhibitor aimed at helping restore normal immune system function in AIDS patients with advanced disease.

Studies worldwide and extensive use of several FDA-approved anticytokine products already affirm the promise of this type of therapy in treating a range of severe and widespread autoimmune diseases. While normal production of the key TNF-α cytokine helps the immune system fight disease, its overproduction may have the contrary effect of promoting not only greater viral replication in AIDS patients, but also a number of mental and physical disorders associated with immune system breakdown.

Advanced Biotherapy plans future studies that will also test a combination of inhibitors including this and other overproduced cytokines that may play a part in this breakdown in AIDS patients in virologic failure. The combined use of such cytokine inhibitors, including inhibitors to TNF-α, interferon-α (IFN-α) and interferon-gamma (IFN-gamma) to treat AIDS is protected by the company's intellectual property.

"This study provides an opportunity to confirm our view that AIDS has an autoimmune component and that we could have a significant effect in controlling this disease by blocking the pathological elements at the source of the immune system breakdown," said Edmond Buccellato, Advanced Biotherapy's CEO. "The results may pave the way for new and exciting therapies for treating AIDS, particularly in those patients who are now unresponsive to antiretroviral drugs."

A complex cellular relationship referred to as the cytokine "network" or "cascade" is responsible for helping the immune system communicate and direct responses against viruses, bacteria, fungi and tumors. HIV appears to disrupt the normal balance of this network. Restoring the functioning of this network may improve the ability of a patient's immune system to fight the AIDS virus.

HIV infection continues to increase in industrial nations, and the numbers associated with the epidemic in certain third-world countries are staggering. According to AVERT, an international HIV and AIDS charity based in the United Kingdom, an estimated 26.6 million people in Sub-Saharan Africa are living with HIV/AIDS, and approximately 3.2 million new cases occurred in 2003. In the past year alone, AIDS has killed 2.3 million Africans. Ten million young people (aged 15-24) and almost 3 million children in Africa under the age of 15 are living with HIV.

Buccellato continued, "We believe that the greatest challenge faced today by clinicians who treat HIV is the management of patients who have developed virologic failure and metabolic complications of anti-HIV treatment. Although treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency or inadequate drug plasma concentration, drug resistance remains the single most important reason for virological failure. More than 50% of patients have detectable plasma HIV RNA despite being on combination highly-active antiretroviral therapy."

The human dimensions and economic burden of AIDS goes well beyond those infected with the disease. According to recent estimates provided by the Washington DC-based AIDS Trust, 25 million children worldwide will become AIDS orphans by 2010. There are about 14 million children worldwide orphaned by AIDS-related deaths, and their number grows by 800,000 per year.

"We are drawn to the plight of these children and believe that this clinical trial is an opportunity for us to dedicate our research and energies on their behalf," Buccellato added.

This article was prepared by AIDS Weekly editors from staff and other reports.

040517
AW040507

Copyright © 2004 - 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.newsrx.net

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the 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.