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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.”
09/16/05
Source
GlaxoSmithKline. Statement to HIV Patient
Community: Information from GlaxoSmithKline on Changes to
Studies of Investigational CCR5 Entry Inhibitor Aplaviroc
(GW873140). September 15, 2005.
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