TABLE 2.
Changes in HIV-1 RNA loads and CD4 and CD8 T-cell counts from baseline to day 9
| Parameter | Result for RDEA806 dose ofa: |
Result for placebo group | |||
|---|---|---|---|---|---|
| 400 mg b.i.d. | 600 mg q.d. | 800 mg q.d. | 1,000 mg q.d. | ||
| No. of subjects per treatment group | 9 | 9 | 9 | 9 | 12 |
| Viral load change (log10 HIV RNA copies/ml) from that at baseline | |||||
| Mean ± SD | −1.948 ± 0.525* | −1.394 ± 0.548* | −1.619* ± 0.385 | −1.696* ± 0.474 | 0.113± 0.271 |
| Median (range) | −1.765* (−3.14 to −1.39) | −1.334* (−2.12 to −0.63) | −1.818* (−2.03 to −1.04) | −1.756* (−2.47 to −0.95) | 0.155 (−0.45 to 0.57) |
| Estimate of difference in HIV-1 RNA load (log10 copies/ml) with treatment vs placebob | −2.0608 | −1.5241 | −1.7426 | −1.8189 | NAc |
| Viral load decay rate (log10 copies/ml/day) | −0.25 | −0.18 | −0.20 | −0.22 | 0.01 |
| No. of subjects with <400 HIV RNA copies/ml | 4 | 3 | 5 | 3 | 0 |
| No. of subjects with viral load decrease of at least 1.0 log10 vs that at baseline | 9 | 7 | 9 | 9 | 0 |
| Mean (range) change in CD4 T-cell count (cells/mm3) from that at baselined | |||||
| CD4 cells | 19.22 (−59.0 to 159.5) | −14.44 (−127.0 to 169.5) | 100.74** (−36.3 to 261.3) | 90.48** (−16.5 to 246.0) | 43.07 (−139.7 to 620.0) |
| CD8 cells | −39.17 (−470.5 to 627.0) | 64.54 (−317.0 to 337.5) | 79.41 (−519.0 to 368.5) | 71.04 (−275.0 to 400.5) | 146.00 (−305.5 to 1,080.0) |
a
*, P < 0.001 for the difference versus the results on day 1 (t test); **, P < 0.05 for the difference versus the results on day 1 (two-sided paired t test).
b
The P value for the difference versus the results for the placebo group was <0.0001 for the four treatment groups, determined using an ANCOVA model that factors treatment and the baseline log10 viral load and with a Bonferroni correction applied.
c
NA, not applicable.
d
Data for percentages of CD4 and CD8 T cells are not shown.