Table 2.
Mean Change From Baseline to Primary Endpoint and Nadir in Plasma HIV-1 RNA
| Parameter | Part 1 | Part 2a | |||||
|---|---|---|---|---|---|---|---|
| (Primary endpoint = Day 11) | (Primary endpoint = Day 8) | ||||||
| GSK’254 10 mg (n = 6) | GSK’254 200 mg (n = 6) | Placebo (n = 2) | GSK’254 40 mg (n = 6) | GSK’254 80 mg (n = 6) | GSK’254 140 mg (n = 6) | Placebo (n = 2) | |
| Plasma HIV-1 RNA (log10 copies/mL), mean (SD) | |||||||
| Baseline | 4.19 (0.31) | 4.82 (0.48) | 4.25 (0.42) | 4.67 (0.23) | 4.43 (0.51) | 4.53 (0.58) | 4.75 (1.78) |
| Primary endpoint | −0.22 (0.31) | −1.96 (0.34) | 0.14 (0.13) | −1.18 (0.44) | −1.02 (0.33) | −1.45 (0.24) | 0.15 (0.23) |
| Nadir | −0.36 (0.25) | −2.01 (0.33) | −0.21 (0.26) | −1.18 (0.44) | −1.02 (0.33) | −1.49 (0.27) | −0.03 (0.13) |
| Modeled plasma HIV-1 RNA rate of change (log10 copies/mL per day), mean (90% CI) | |||||||
| Primary endpointb | −0.02 (−.04 to .01) | −0.22 (−.24 to −.20) | 0.02 (−.02 to .06) | −0.21 (−.23 to −.19) | −0.17 (−.19 to −.15) | −0.25 (−.27 to −.22) | 0.01 (−.03 to .05) |
| Modeled plasma HIV-1 RNA maximum change (log10 copies/mL), mean (90% CI) | |||||||
| Nadirc | −0.34 (−.67 to −.00) | −1.93 (−2.24 to −1.62) | −0.07 (−.58 to .45) | −1.05 (−1.29 to −.82) | −0.94 (−1.16 to −.72) | −1.49 (−1.70 to − 1.28) | −0.02 (−.39 to .36) |
Abbreviations: CI, confidence interval; GSK’254, GSK3640254; HIV-1, human immunodeficiency virus type 1; SD, standard deviation.
Assessments on days 10–12 are excluded from nadir calculation because of administration of combination antiretroviral therapy from day 8 in part 2.
Change from baseline model estimates were generated using a mixed-effects model with baseline, treatment day, treatment, and treatment × treatment day as main effects and participant as a random effect.
Nadir model estimates are least squares means generated using a mixed-effects model with baseline, treatment, and treatment × baseline as main effects.