Table 4.
Elevations in alanine aminotransferase (ALT) levels in relation to rifampin and desacetyl-rifampin concentrations by participant
| Arm 1/participant number | 001 | 003 | 007 | 009 | 012 | 013 | 015 | 017 | |
|---|---|---|---|---|---|---|---|---|---|
| Maximum ALT increase (X-fold the ULN) | 5X | 8X | 1.8X | ↔ | 1.6X | 1.05X | ↔ | ↔ | |
| Fold increase in rifampin concentration | ND | ND | ND | ↔ | ↔ | ↔ | ND | 10X | |
| Fold increase in desacetyl-rifampin concentration | ND | ND | ND | ND | 4X | 4X | ND | 7X | |
| Rifampin total doses | 5 | 4 | 4 | 1 | 2 | 2 | 2 | 1 | |
| Saquinavir/ritonavir total doses | 37 | 36 | 36 | 29 | 31 | 31 | 31 | 29 | |
| Days on saquinavir/ritonavir and rifampin | 5 | 4 | 4 | 1 | 2 | 2 | 2 | 1 | |
| Arm 2/participant number | 002 | 004 | 005 | 008 | 010 | 011 | 014 | 018 | 019 |
| Maximum ALT increase (X-fold the ULN) | 11X | 70X† | 40X | 15X | 12X† | 50X | 21X | 33X | 67X |
| Fold increase in rifampin concentration | ND | 10X | ND | ↔ | ↔ | 2X | ND | ↔ | ↔ |
| Fold increase in desacetyl-rifampin concentration | ND | 19X | ND | 2X | ND | 4X | ND | ND | 3X |
| Rifampin total doses | 18 | 16 | 16 | 16 | 15 | 15 | 15 | 15 | 15 |
| Saquinavir/ritonavir total doses | 8 | 3 | 3 | 3 | 1 | 1 | 1 | 1 | 1 |
| Days on saquinavir/ritonavir and rifampin | 4 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
†
Abnormal at end of treatment with rifampin alone.
ND = Not determined (sample taken too late with a concentration below the limit of quantification or no sample taken); ULN = Upper limit of normal; ↔ = no change.