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HIGHLIGHTS FROM ICAAC �97

The CHEESE Study (M61003) FORTOVASE� vs. indinavir

Dr. J. Borleffs of University Hospital, Utrecht, presented data from the first head-to-head comparative study of two protease inhibitor-containing triple combination regimens. This randomized, open-label, parallel-group, multicenter pilot study compared FORTOVASE + AZT + 3TC versus indinavir + AZT + 3TC. Subjects were HIV-infected, either antiretroviral-na�ve or < 12 months� AZT experience, CD4 < 500 and/or HIV RNA of > 10,000 and/or HIV-related signs or symptoms.

The results at week 12 showed that both the FORTOVASE and indinavir regimens were equally effective in suppressing viral load, demonstrating mean decreases from 5.17 log10 and 5.70 log10 to 2.6 log10, respectively. All study participants achieved HIV RNA levels below the limit of detection using the Roche Amplicor� commercial assay.

The mean CD4 count rose 40 percent in the subjects taking FORTOVASE, versus an increase of only 2 percent in those subjects taking indinavir. No adverse effects related to FORTOVASE were reported.

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