Boston, Galveston, Jackson County, Jefferson County, New York City, Portland -- New Saquinavir Trial

Hoffmann-La Roche is recruiting for a 90-patient trial to compare different doses of a new formulation of saquinavir, its protease inhibitor, with the conventional formulation now being used in major clinical trials and in the expanded-access lottery. The new formulation is the same drug, but delivered in such a way as to minimize the problem of the low bioavailability (low absorption when the drug is taken orally) of saquinavir.

This trial will test different doses of the new formulation, to deliver blood levels between those now attained in the major saquinavir trials, and the levels attained in the high-dose trial at Stanford (see "Saquinavir -- Roche Protease Inhibitor -- At Higher Doses," in this issue). Persons in this study will be randomly assigned to one of four groups: the current formulation at the dose used in the major trials (600 mg every 8 hours), or the new formulation at either 400 mg, 800 mg, for 1200 mg, every 8 hours, for 8 weeks. "After 8 weeks, participants will be permitted to continue on their randomized study drug in conjunction with the treatment of their choice. Once an optimal dose is identified, patients will be offered the optimal dose as monotherapy, or in combination with the other antiretroviral therapies. The study period will last until the new formulation is approved."

Persons eligible for this study must be 18 or older, have a CD4 count between 100 and 500, have a viral load of more than 20,000 copies, and not have been treated with a protease inhibitor before. This study is still enrolling in 6 geographic areas: Boston; Galveston; Jackson County, Missouri; Jefferson County, Alabama; New York City; and Portland, Oregon. For more information, either call Roche at 800/526-6367, or call the AIDS Clinical Trials Information Service at 800/TRIALS-A.