The Body Covers: The 37th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Saquinavir Soft Gel Capsules Versus Indinavir as Part of AZT and 3TC Containing Triple Therapy
September 28-October 1, 1997
The Dutch are to be congratulated for performing one of the first head to head comparisons of two protease containing triple combination regimens.
This study is known as the CHEESE study (don't ask, it is an acronym and we can only hope it doesn't continue the trend in cute names, after CAESAR and INCAS). It is an ongoing, open label study comparing two triple drug regimens containing AZT and 3TC with either indinavir or the new soft gel capsule of saquinavir at a dose of 1200 mg 3 times daily. The soft gel is also known as enhanced oral formulation or EOF, soon to be approved and marketed as "Fortivase." 1200 mg three times daily of the new formula gives 10 times the blood levels of the old capsule at 800 mg three times daily.
Patients in this study could have taken AZT for up to 12 months but no other treatments. Forty-four patients have been randomized and data are available up to 12 weeks. At 12 weeks, all patients have viral loads below 400 copies in both arms, down from a baseline of about 80,000 (log 4.8 for the non-mathematically challenged). Side effects were similar in the two groups.
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