TABLE 1.
Subject | APL dose (mg) | Visitb | Population tropism | RT/PRO mutations | CD4 count (cells/mm3)c | CD4 count change (cells/mm3) | Log10 HIV-1 RNA (c/ml)c | HIV-1 RNA change (c/ml) | APL FCIC50 (fold) | APL MPI (%) |
---|---|---|---|---|---|---|---|---|---|---|
P1 | 200 BID | Day 1 | R5 | 77 | 6.256 | 0.90 | 98.8 | |||
Week 20 | R5 | WT | NT | NT | 4.360 | −1.896 | 1.37 | 97.5 | ||
P2 | 400 BID | Day 1 | R5 | K103N | 365 | 4.652 | 0.53 | 95.0 | ||
Week 8 | R5 | K103N | 606 | 241 | 4.987 | 0.335 | 0.64 | 91.6 | ||
P3 | 800 QD | Day 1 | R5 | 124 | 5.121 | 0.76 | 97.3 | |||
Week 16 | DM | WT | 162 | 38 | 4.260 | −0.861 | 0.92 | 93.3 | ||
P4 | 800 QD | Day 1 | R5 | 175 | 5.885 | 1.09 | 99.5 | |||
Week 4 | R5 | WT | 218 | 43 | 5.860 | −0.025 | 1.11 | 99.8 | ||
P5 | 800 QD | Day 1 | R5 | 125 | 4.654 | 0.66 | 72.5 | |||
Week 12 | DM | WT | 122 | −3 | 4.583 | −0.071 | 1.36 | 70.7 | ||
P6 | 800 QD | Day 1 | R5 | 172 | 4.619 | 0.77 | 98.4 | |||
Week 4 | R5 | WT | 284 | 112 | 4.356 | −0.263 | 0.67 | 99.0 | ||
P7 | 800 QD | Day 1 | R5 | M41L | 334 | 5.481 | 0.80 | 99.6 | ||
Week 20 | R5 | M41L | 363 | 29 | 5.405 | −0.076 | 0.77 | 99.2 | ||
P8 | 400 BID | Day 1 | DM | NA | 187 | 4.889 | 0.30 | 99.5 | ||
Week 4 | DM | NA | 213 | 26 | 4.918 | 0.029 | 0.18 | 99.7 | ||
P9 | 800 QD | Day 1 | R5 | NA | 617 | 4.107 | 1.23 | 96.9 | ||
Week 12 | R5 | NA | 1182 | 565 | 3.528 | −0.579 | 0.62 | 93.9 | ||
P10d | 200 BID | Day 1 | DM | 109 | 5.624 | 0.75 | 96.9 | |||
Week 12 | DM | WT | 178 | 69 | 5.667 | 0.043 | 0.73 | 98.6 | ||
P11 | —e | Day 1 | R5 | K103N | 342 | 5.243 | 0.57 | 99.0 | ||
Week 20 | R5 | K103N | 564 | 222 | 3.511 | −1.732 | 0.95 | 98.2 |
NA, value could not be determined; NT, not tested; WT, wild-type sequence detected.
Visits other than on day 1 indicate the virologic failure time point.
Single value per time point, determined as described in Materials and Methods.
Subject was DM-tropic at enrollment.
Subject received lamivudine-zidovudine/LPV-r without APL.