Efficacy Results From CONTEXT

A total of 320 (315 treated) PI-experienced HIV+ patients experiencing virologic failure (plasma HIV-1 RNA viral load of ?1,000 copies/mL) were enrolled in the CONTEXT study. Forty percent of study participants had prior treatment experience with two or more PIs, 74 percent had experience with 3 or more nucleoside reverse transcriptase inhibitors (NRTIs), and 57 percent had received prior therapy with non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Patients were randomized to receive either 1400 mg of 908 QD combined with low dose ritonavir (200 mg QD) (n=105), 700 mg of 908 combined with 100 mg ritonavir BID (n=107), or 400 mg lopinavir/100 mg ritonavir BID (n=103). All three groups took the medications in combination with two active NRTIs. Baseline vRNA (median 4.14 log10 copies/mL) and CD4+ cell counts (median 263 cells/mm3 ) were similar among the treatment arms.

By intent-to-treat analysis at 24 weeks, the mean AAUCMB (log10 c/mL) was -1.48 for patients on 908/r QD, -1.50 for those on 908/r BID and -1.66 for those taking LPV/r BID, according to DeJesus. Positive antiviral responses were seen with both the 908/r and LPV/r regimens, with 48 percent, 42 percent and 40 percent achieving <50 c/mL responses in the LPV/r, 908/r QD and 908/r BID arms, respectively. The median change from baseline in CD4 cells/mm3 was 72 for 908/r QD, 62 for 908/r BID and 63 for LPV/r BID.

Safety Results from CONTEXT

In the CONTEXT trial, the incidence of drug-related adverse events (AEs) of at least moderate severity was low, occurring in 19 percent of patients on 908/r QD (n=20), 35 percent on 908/r BID (n=37) and 34 percent on LPV/r BID (n=35). The most common AEs were diarrhea (5 percent, 10 percent and 8 percent, respectively) and nausea (4 percent, 3 percent and 9 percent, respectively). Additionally, mo
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Contact: Amy Kling
akling@pcipr.com
312-558-1770
Public Communications Inc.
14-Feb-2003