Statement to HIV Patient Community from GlaxoSmithKline
(September 15, 2005) - GlaxoSmithKline (GSK) is informing you that we are making changes to the development program for the investigational CCR5 entry inhibitor, aplaviroc (GW873140), due to safety data observed in Phase IIb studies.
GSK has received reports of severe hepatotoxicity with elevated liver enzymes (AST, ALT) and total bilirubin in clinical trials involving treatment-naïve patients. GSK has taken immediate steps to protect the welfare of patients in clinical studies of aplaviroc.
After review of these liver toxicity findings with the US Food and Drug Administration, GSK has terminated the aplaviroc clinical trials in treatment-naïve patients. In addition, GSK is amending its ongoing Phase III studies in treatment-experienced patients to implement additional safety monitoring requirements and changes to patient inclusion/exclusion criteria.
Treatment-experienced patients already enrolled in the Phase III studies may elect, in discussion with their physician-investigator, to continue on their study medication, but will be monitored closely for signs or symptoms of hepatotoxicity and/or elevations in liver function tests.
Clinical trial investigators and their IRBs have been notified of the situation and how to handle the treatment of the patients involved. A protocol amendment for Phase III studies involving treatment-experienced patients will be forthcoming in the next week and will include a revised informed consent form.
“GSK is committed to excellence in the care of individuals with HIV infection, and we are taking all necessary steps to protect the safety and health of these clinical trial participants,” said Lynn Marks, MD, Senior Vice President, GSK Medicine Development Centre, Infectious Diseases.
“While we are stopping our work in treatment-naïve patients, we are proceeding cautiously with treatment-experienced HIV patients who need new treatment options. We are working closely with regulatory authorities, the clinical trial sites and the patients involved in these studies. Patient safety remains our major focus.”
GlaxoSmithKline. Statement to HIV Patient Community: Information from GlaxoSmithKline on Changes to Studies of Investigational CCR5 Entry Inhibitor Aplaviroc (GW873140). September 15, 2005.