TABLE 1.
Study group (regimen) and animal identifier | Animal wta (kg) | Animal ageb (mo) | No. of measurements below LOQc (%) | Mean plasma drug concn, ng/ml (95% confidence limit) | % Drug applied detected in plasma at 30 mind (95% confidence limit) |
---|---|---|---|---|---|
TFV (TFV only) | |||||
PRa2 | 6.36 | 65 | 6 (30) | 22.4 (13.8-31.0) | 0.016 (0.010-0.022) |
PVb2 | 6.96 | 61 | 9 (45) | 15.4 (10.0-20.9) | 0.012 (0.008-0.016) |
PHb2 | 8.22 | 63 | 13 (65) | 13.6 (6.0-21.2) | 0.012 (0.005-0.019) |
PEc2 | 6.54 | 60 | 10 (50) | 21.2 (9.7-32.7) | 0.015 (0.007-0.024) |
PUc2 | 6.76 | 56 | 11 (55) | 15.3 (6.7-23.9) | 0.011 (0.005-0.018) |
PYh1 | 11.62 | 146 | 9 (45) | 11.2 (8.9-13.5) | 0.014 (0.011-0.017) |
Total | 7.74 | 75 | 58 (48) | 16.4 (13.1-19.7) | 0.014 (0.011-0.017) |
TFV (TFV-FTC) | |||||
PRa2 | 6.36 | 65 | 4 (20) | 34.7 (16.6-52.7) | 0.024 (0.012-0.037) |
PVb2 | 6.96 | 61 | 2 (10) | 52.0 (17.6-86.4) | 0.040 (0.013-0.066) |
PHb2 | 8.22 | 63 | 3 (15) | 25.3 (19.6-30.9) | 0.023 (0.018-0.028) |
PCt1 | 8.00 | 95 | 4 (20) | 38.1 (17.4-58.8) | 0.034 (0.015-0.052) |
PSc2 | 6.54 | 58 | 2 (10) | 49.2 (25.8-72.7) | 0.035 (0.019-0.052) |
PDe2 | 5.86 | 50 | 6 (30) | 33.1 (14.0-52.2) | 0.021 (0.009-0.034) |
Total | 6.99 | 65 | 21 (18) | 38.7 (29.6-47.8) | 0.030 (0.023-0.037) |
FTC (TFV-FTC) | |||||
PRa2 | 6.36 | 65 | 0 (0) | 133.6 (45.6-221.6) | 0.019 (0.006-0.031) |
PVb2 | 6.96 | 61 | 2 (10) | 155.9 (41.2-270.7) | 0.024 (0.006-0.041) |
PHb2 | 8.22 | 63 | 0 (0) | 124.6 (76.2-173.0) | 0.023 (0.014-0.031) |
PCt1 | 8.00 | 95 | 4 (20) | 187.4 (43.2-331.6) | 0.033 (0.008-0.058) |
PSc2 | 6.54 | 58 | 0 (0) | 228.3 (103.6-352.9) | 0.033 (0.015-0.051) |
PDe2 | 5.86 | 50 | 0 (0) | 131.4 (36.7-226.2) | 0.017 (0.005-0.029) |
Total | 6.99 | 65 | 6 (5) | 160.2 (116.1-204.3) | 0.025 (0.018-0.031) |
Baseline weight measured prior to first SHIV challenge.
Age of macaque at start of study.
The LOQ for both TFV and FTC was 10 ng/ml.
Calculated by dividing the weight-adjusted plasma drug concentration (estimated assuming a plasma volume of 33 ml/kg) (8) by the amount of drug applied (0.03 g TFV; 0.15 g FTC).