PI Perspect. 1995 May;(no 16):8-9. Unique Identifier : AIDSLINE AIDS/95700459 Cheng B
Abstract:
Advances in protease inhibitor clinical studies are discussed for the following inhibitors: Merck MK-639, Abbott ABT-538, Hoffman-La Roche saquinavir, and Agouron AG1343. It is noted that results from a phase II study of MK-639 are showing impressive antiviral activity with the only significant side effects being hyperbilirubinemia, and at high doses, development of kidney stones. Cross resistance started developing in long-term users of the drug. ABT-538 is also showing impressive antiviral activity in both European and U.S. phase I/II studies, and three further studies are planned, involving AZT-experienced volunteers. Currently, there are no plans to provide ABT-538 through an early access program. At higher doses than used in earlier studies, saquinavir is also showing increased antiviral activity. Doses now need to be two or three times higher than the dose being studied in earlier Phase III studies due to poor drug bioavailability. Early results from a pilot Phase II study of AG1343 are also showing clear evidence of antiviral activity with no serious adverse side effects reported. Only one dose level has been studied thus far.
Keywords: Clinical Trials, Phase I Clinical Trials, Phase II Clinical Trials, Phase III CD4 Lymphocyte Count Drug Design Human HIV Protease Inhibitors/*THERAPEUTIC USE Pyridines/THERAPEUTIC USE NEWSLETTER ARTICLE 951230
M95C3175
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