Glaxo Wellcome has begun Phase II clinical trials with the VertexPharmaceutical-discovered HIV protease inhibitor 141W94/VX-478, in combination with other HIV protease inhibitors. This is the second trial to look at the combination of protease inhibitors (Marketletter July 22, 1996). The drug's development is being undertaken by GW, Kissei Pharma of Japan and Vertex.
The 24-week, open-label, Phase II study is designed to test the tolerability, pharmacokinetics and antiviral efficacy of double HIV protease regimens including 141W94/VX-478 plus either Roche's saquinavir, Merck & Co's indinavir or Agouron's nelfinavir. A fourth group treated with VX-478 plus GW's Retrovir (zidovudine) and Epivir (lamivudine) will provide a comparison arm. The study is expected to enroll about 48 HIV-positive adults.
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