GlaxoSmithKline Suspends Phase III Trial of AIDS Drug After Two Participants Develop Severe Liver Toxicity
September 19, 2005
GlaxoSmithKline last week in a statement to the HIV/AIDS patient community said it has suspended a Phase III trial of the experimental antiretroviral drug aplaviroc after two HIV-positive participants who were taking the drug developed severe liver toxicity, the Wall Street Journal reports. The two participants are among 250 HIV-positive volunteers in the trial -- which has sites in the U.S., Canada and the European Union -- who are newly diagnosed and who have never received treatment for HIV. Neither of the patients died nor required liver transplants. The company discussed the drug's risks with FDA and said it suspended the trial "in the interests of safety," although it was not clear that the liver problems were drug-related, GSK spokesperson Rick Koenig said. Aplaviroc is in a new class of drugs known as entry inhibitors that prevent HIV from entering cells. The treatment-naive patients were receiving aplaviroc in addition to standard HIV treatment, and a control group of 50 volunteers were receiving standard treatment without the experimental drug.
Treatment-Experienced Patients Allowed to Continue
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Vicriviroc (SCH 417690, SCH-D), a CCR5 Antagonist, Generally Well Tolerated and Effective in 14-Day Monotherapy Study
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