Table 2.
Change in HIV-1 RNA and CD4+ T cells
| PRO 140 |
||||
|---|---|---|---|---|
| Effect | Placebo | 162mg Weekly | 324mg Biweekly | 324mg Weekly |
| Maximum log10 change in HIV-1 RNA | −0.23±0.29 | −0.99±0.56 (p=0.0093) | −1.37±0.89 (p=0.0001) | −1.65±0.57 (p<0.0001) |
| Day 22 log10 change in HIV-1 RNA | −0.15±020 | −0.75±0.41 (p=0.0072) | −1.20±1.00 (p=0.0001) | −1.51±0.65 (p<0.0001) |
| Number of subjects with ≥1 log10 decrease in HIV-1 RNA at any time post-treatment, (%)† | 0/10 (0%) | 6/11 (55%) (p=0.012) | 9/12 (75%) (p=0.0005) | 10/11 (89%) (p<0.0001) |
| Number of subjects with <400 copies HIV-1 RNA/mL at any time post-treatment, (%) | 0/10 (0%) | 1/11 (11%) | 2/12 (17%) | 8/11 (73%) (p=0.001) |
| Median (range) change in CD4+ cell count at Days 8, 15 and 22, cells/μL | 4 (−70–+71) | 29 (−169–+198) | 104 (−97–+317) | 76 (−52–+219) |
| 12 (−101–+104) | 50 (−204–+278) | 44 (−46–+178) | 76 (−84–+ 246) | |
| 14 (−184–+179) | 55 (−140–+153) | 99 (−21–+243) | 84 (−110–+296) | |
NOTE: Data are mean ± SD values unless otherwise indicated
†
Includes one subject each in the 324mg biweekly and 324mg weekly groups with a 0.99 log10 reduction in HIV-1 RNA