Table 4.
Target Mononuclear Cell Values of Drugs From DcNP for Current ATV-RTV-TFV DcNP and Previously Reported TLC-ART 101 Containing LPV, RTV, and TFV
| Parameter | DcNP Containing ATV |
DcNP Containing LPV (TLC-ART 101) |
||||
|---|---|---|---|---|---|---|
| ATV | RTV | TFV | LPV | RTV | TFV | |
| AUCPBMC (h·μM) | 435a (302-580) | 85 (9-150) | 1134 (588-1554) | 79a (33-120) | 52 (16-92) | 435 (166-987) |
| LNMC | ||||||
| 24 h (μM) | 0.10 (0.04-0.24) | 0.40a (0.06-3.00) | NA | 14 (6-40) | 6.3a (4.4-8.5) | 25 (14-47) |
| 192 h (μM) | 0.09b | 0.35b | 0.13b | 5 0.0 (0.4-13.1) | 1.00 (0.06-2.00) | 19 (3.6-280) |
| LNMC/plasma | ||||||
| 24 h | 13 (6-25) | 21.2 (9.5-75.0) | NA | 90 (13-700) | 78 (18-280) | 3 (1.5-5.3) |
| 192 h | 69 | 23b | 80b | 198 (128-560) | – | 6.8 (1.4-75) |
| LNMC/PBMC | ||||||
| 24 h | 0.7 (0.02-5.02) | 1.0a (0.3-3.8) | – | 23 (8-170) | 8.9a (3.9-13.0) | 0.93 (0.39-2.3) |
| 192 h | 2.4b | 0.7b | – | 79 (51-170) | – | 4.4 (0.45-340.0) |
Geometric Mean (95% CI).
Free drugs scaled to equivalent DcNP dosages. DcNP containing ATV drugs scaled to equivalent DcNP containing LPV (TLC-ART 1014) drug dosages. DcNP containing LPV (TLC-ART 101) drugs and free LPV values were taken from previous TLC-ART 101 study.4 AUCPBMC, area under the PBMC drug concentration-time curve extrapolated to infinity; –, not detected; NA, not available.
a
Unpaired t-test p <0.05 between nanoformulations.
b
n = 2.