Table 2.
BENCHMRK-1 |
BENCHMRK-2 |
|||
---|---|---|---|---|
Raltegravir | Placebo | Raltegravir | Placebo | |
n | 232 | 118 | 230 | 119 |
Age | 46.1 | 43.7 | 45.3 | 46.5 |
Male | 84.1% | 87.3% | 91.3% | 89.9% |
Baseline CD4 count (mean) | 156.4 | 152.8 | 146.4 | 163.2 |
Baseline HIV-1 RNA (mean) log10 copies/mL | 4.6 | 4.5 | 4.7 | 4.7 |
AIDS diagnosis | 93.5% | 89.8% | 90.9% | 92.4% |
Prior antiretroviral use in years (median) | 10.6 | 10.3 | 9.6 | 10.1 |
Number of antiretrovirals used in the past | 12 | 12 | 12 | 12 |
Enfurvitidea in optimized background regimen | 37.9% | 36.4% | 37.8% | 38.7% |
Resistance to ≥PIs | 97% | 94.9% | 96.5% | 95.8% |
Derived from Isentress FDA Briefing Document 2007.
Includes those already enfuvirtide experienced.
Abbreviation: PIs, protease inhibitors.