International Committee Unveils Initial Plans to Look at Long-Term Use of HIV Treatment

International Committee Unveils Initial Plans to Look at Long-Term Use of HIV Treatment

Business Wire - January 31, 2000

SAN FRANCISCO--(BUSINESS WIRE)--Jan. 31, 2000--The Steering Committee for the Evaluation of Metabolic Complications of HAART (highly active antiretroviral therapy) will unveil its initial plans today at a symposium at the 7th Conference on Retroviruses and Opportunistic Infections in San Francisco to investigate the long-term effects associated with the use of HIV medications. The international committee, established in May 1999, was formed to evaluate the possible short- and long-term complications of HIV antiretroviral medications, specifically body composition changes (referred to as "lipodystrophy"), metabolic changes (disturbances of lipid and glucose metabolism) and the potential for the development of cardiovascular events.

The steering committee is dedicated to examining the safety issues presumed to be associated with HAART, the standard of care for people with HIV infection. HAART is credited with significant reductions in the incidence of AIDS and mortality from HIV infection.

"Research that actually examines the relationship between the long-term use of life-saving HAART regimens and the metabolic and body composition changes is necessary," said Professor Ian Weller, committee co-chair and head of the Department of STDs, Royal-Free and University College Medical School, London. "In a short period of time, industry members as well as academians pooled resources and were able to develop protocols, generate funding and start research programs, demonstrating their commitment to examine metabolic and cardiovascular complications."

"HAART has undoubtedly contributed to dramatic improvements in the care of those living with HIV," said Committee Chairman David Pizzuti, M.D., vice president of medical affairs at Abbott Laboratories. "Unlike other medications, antiretrovirals have a short therapeutic history and long-term effects are not fully understood. It is the responsibility of our industry, along with researchers, to further evaluate these complex issues."

Because previous clinical trial safety data did not provide sufficient information with respect to body composition and metabolic changes due to the small sample sizes and limited duration of therapy, the steering committee developed recommendations to ensure these issues are better addressed moving forward.

The committee's report outlined key initiatives for 2000, including:

-- A case-control analysis of 800 patients from 20 sites orldwide that would serve as the foundation for the development f a case definition of lipodystrophy and metabolic omplications; experts have noted the extremely complicated ature of the metabolic changes associated with HIV infection ndependent of treatment and seek to work toward a uniform efinition of the complications associated with HAART.

-- A meta-analysis of current collaborative clinical trials to obtain objective data regarding short-term metabolic abnormalities related to body composition changes and lipid and glucose abnormalities; the analysis will provide additional insight into the incidence of these abnormalities in all HIV clinical trial participants who have taken antiretroviral medications, including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors.

-- A prospective cohort study of the risk of cardiovascular vents in HIV patients on HAART; the study will monitor 15,000 IV patients from around the world for two years to determine hether there is an increased risk for cardiovascular adverse vents when patients are receiving HAART.

-- A retrospective cohort study of the risk of cardiovascular vents among HIV patients on HAART is under consideration.

The 24-member committee, which first convened last May at the request of the European Medicines Evaluation Agency (EMEA), is comprised of HIV specialists, academic and regulatory consultants, members of the HIV patient-advocacy community and pharmaceutical industry researchers from around the world.

Committee members include: David Pizzuti, M.D., Abbott Laboratories; Ronald Lewis, M.D., Agouron; Steven Schnittman, M.D., Bristol Myers Squibb; Patrick Robinson, M.D., and Geoffrey Cotton, M.D., Boehringer Ingelheim; Thomas Mertenskoetter, M.D., Glaxo Wellcome; Joan Benson, M.D., Merck & Co; William Freimuth, M.D., and Massimiliano Mucci, M.D., Pharmacia Upjohn; Frank Duff, M.D., Hoffmann-LaRoche; Marco Silleni, M.D., Du Pont Pharmaceuticals; Professor Ian Weller, Royal Free University College and Medical School, London; Professor Bo Odlind, Swedish EMEA; Bo Aronsson, M.D., EMEA; Andrew Carr, M.D., St. Vincent's Hospital, Sydney, Australia; Janet Darbyshire, M.D., Medical Research Council, London; Barry Goldstein, M.D., Jefferson Medical Center, Philadelphia; Carl Grunfeld, M.D., University of California, San Francisco; Jens Lundgren, M.D., EuroSIDA, Denmark; Orjan Mortimer, M.D., MPA, Sweden; Jeff Murray, M.D., U.S. Food and Drug Administration; Andrew Phillips, Ph.D, Royal Free Hospital, London; James Shepherd, Ph.D, University of Glasgow, Scotland; Alec Walker, Ph.D., Harvard School of Public Health; Raffi Babakhanian, European AIDS Treatment Group; Bob Munk, New Mexico InfoNet.

CONTACT: For Abbott Laboratories Lisa Richardson, 312/729-4149 Nikki Levy, 312/729-4248
000131
BW000108

Copyright © 2000 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.

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, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 2000. 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, 2000. 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. .