AEGiS-AIDSWeekly: HIV/AIDS: Clinical effectiveness and tolerability of Fosalvudine (HIV) confirmed

Important note: Information in this article was accurate in June 2007. The state of the art may have changed since the publication date.

HIV/AIDS: Clinical effectiveness and tolerability of Fosalvudine (HIV) confirmed

AIDSWEEKLY Plus; Monday, June 4, 2007
Staff Medical Writers

NewsRx -- Heidelberg Pharma AG announced the successful completion of a clinical Phase II study with the developing agent Fosalvudine against HIV/AIDS. The objective of this placebo-controlled, double blind clinical study was to survey the effectiveness, tolerability and pharmacokinetic properties during a treatment period of 14 days. Under the supervision of Dr. Schürmann from the Berlin Charité and Dr. Cahn from the Fundación Huésped in Buenos Aires (Argentina), four dosages were tested on a total of 44 HIV-infected patients who had not been treated up until then. The substance achieved a dosage-dependant decrease of the viral load to ca. 7% of the initial value (1,13 log levels) and therewith confirmed the therapeutical effectiveness within this patient group. The tolerance of the given dosages was also proven. "We are very satisfied with the result of this study", says Dr. Erwin Böhm, responsible for the clinical development at Heidelberg Pharma AG. "The effectiveness and tolerance of Fosalvudine have encouraged us to take the next hurdle, to run a clinical study within resistant HIV patients. The results confirm the concept of EPD Technology, which aims at increasing the therapeutical amplitude of active agents. It is our goal to develop a drug for patients who are infected with resistant HIV clades. Tackling resistant viruses is a great challenge within the AIDS therapy."

Fosalvudine

The Enhanced Pro-Drug Fosalvudine is a nucleotide reverse transcriptase inhibitor during the treatment of HIV-1 infections with the emphasis on therapy-resistant HIV-1 clades. The intake of Fosalvudine leads to the intracellular supply of Fluorothymidin-Monophosphat. This is processed further by cellular enzymes to active fluorothymidine triphosphate - an effective inhibitor of the reverse transcriptase of HIV. Fosalvudine produced the same active metabolite as the related compound Alovudine. Alovudine is a reverse transcriptase inhibitor, which acts against NRTI-resistant HIV with thymidine-related mutations but has a narrow therapeutic window. When administered orally, Fosalvudine has the potential for a wider therapeutic window due to the lower side-effects with comparable effectiveness.

Keywords: HIV/AIDS, AIDS, Acquired Immunodeficiency Syndrome, Clinical Trial Research, HIV, Human Immunodeficiency Virus, Pharmaceuticals, Virology, Heidelberg Pharma.

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

2007-06-04
AW070601

Copyright © 2007 - 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, Bridgestone/Firestone Charitable Trust, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2007. 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 © 1980,2007. 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.