acebo (604 patients), each given in
addition to a BR. For all patients, the BR included darunavir/ritonavir,
plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with
or without enfuvirtide). The study remained double-blinded through
48-Week Efficacy Findings
-- In DUET-1, 60 percent of patients in the INTELENCE arm had a confirmed
undetectable viral load at 48 weeks compared with 39 percent of those
in the placebo arm [p<0.0001].
-- In DUET-2, 61 percent of patients in the INTELENCE arm had a confirmed
undetectable viral load at 48 weeks compared with 41 percent of those
in the placebo arm [p<0.0001].
-- In DUET-1, the mean increase in CD4+ cell count from baseline was
103 cells/mm3 in the INTELENCE arm compared with 74 cells/mm3 in the
placebo arm [p=0.0025].
-- In DUET-2, the mean increase in CD4+ cell count from baseline was
94 cells/mm3 in the INTELENCE arm compared with 72 cells/mm3 in the
placebo arm [p=0.0160].
48-Week Safety Findings
In DUET-1, the most commonly reported adverse events among patients in
the INTELENCE arm vs. placebo arm were rash of any type (22 percent vs. 11
percent), diarrhea (14 percent vs. 24 percent), and nausea (15 percent vs.
In DUET-2, the most commonly reported adverse events among patients in
the INTELENCE arm vs. placebo arm were diarrhea (22.0 percent vs. 22.6
percent), rash of any type (16.6 percent vs. 11.1 percent) and nausea (14.6
percent vs. 10.8 percent).
Important Safety Information
INTELENCE(TM) does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
-- Severe and potentially life-threatening skin reactions, including
Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema
multiforme, have occurred (<0.1 percent) in patients taking INTELENCE.
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