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  • Title: Protease inhibitor trials moving to next phase.
    Journal: AIDS Alert; 1995 Aug; 10(8):100-1. PubMed ID: 11362675.
    Abstract:
    Hoffmann-La Roche and Agouron Pharmaceuticals are establishing large clinical studies in the United States of their protease inhibitors. La Roche is set to begin its Phase III trial of Invirase (saquinavir), which will study the drug alone and in combination with other antiretrovirals. The trial, NV14256, includes 1,000 patients with advanced HIV disease who are no longer tolerant to zidovudine (AZT, Retrovir) and who have a CD4 count between 50 and 300. A concurrent international Phase III trial of saquinavir will involve 3,300 patients who have had little or no AZT treatment. Roche will also begin a compassionate-treatment program that will supply saquinavir to patients unable to meet the stringent requirements of the clinical trials. Agouron is expected to enter Phase III trials for its protease inhibitor, AG1343. A monotherapy trial will look at optimal dosing, durability, and resistance patterns of the drug. A second trial will combine AG1343 with the antiretroviral, stavudine (D4T). A third trial will look at the stavudine-AG1343 combination in late-stage patients, and will compare standard-of-care treatment with AG1343 to standard-of-care treatment and placebo. In Agouron's Phase I/II trials for AG1343, results showed up to a 95 percent reduction in viral load throughout the first 4 weeks of treatment for patients. CD4 counts rose as much as 120 in some patients in the first 9 days. Although there is excitement about the four protease inhibitors currently being tested, questions about resistance continue.
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