Third Pivotal Trial For 141W94; Filing In 1998

Vertex Pharmaceuticals and Glaxo Wellcome have begun a third Phase IIIclinical trial comparing the safety and efficacy of their HIV protease inhibitor 141W94 (VX-478) plus a nucleoside reverse transcriptase inhibitor to the safety and efficacy of Merck & Co's Crixivan (indinavir) plus an RTI.

GW has also confirmed that a Phase III study of 141W94, initiated earlier this year in adults, has now completed enrollment. Data generated from the 16-week enpoint in these trials are intended to support filing for marketing approval, expected in 1998.

The newly-initiated trial is an open-label, randomized study, designed to compare the antiviral efficacy, tolerability and durability of the antiviral response of 141W94 (1,200mg, taken twice daily) compared to indinavir (800mg taken three times daily) in combination with current RTI therapy. The primary objective will be to assess the antiviral efficacy of treatment groups at 16 weeks and 48 weeks and to assess the ability of the drugs to suppress virus to undetectable levels. To determine if patients are responding to therapy, real-time viral load measurements will be performed. The study is expected to enroll approximately 460 RTI-experienced, protease inhibitor-naive HIV-infected adults.