GlaxoSmithKline
is suspending a Phase III clinical trial of its
experimental HIV entry inhibitor aplaviroc after two
HIV-positive trial participants developed severe liver
damage, The Wall Street Journal reports.
Although it was not initially clear whether the liver
problems were related to the drug, Glaxo made the
decision to suspend the trial after discussing the
drug's risks with the Food and Drug
Administration. Neither of the trial participants died nor
required liver transplants, according to Glaxo. They were
among 250 treatment-naive HIV-positive people in the
United States, Canada, and the European Union
participating in the clinical trial. A separate trial
involving treatment-experienced HIV-positive people will
continue, although participants will be closely
watched for signs of liver toxicity, says Glaxo
spokesman Rick Koenig. The study will not, however,
enroll new participants until the company has a better
understanding of the cause of the liver-related side
effects. (Advocate.com)