Table 2.
Baseline antiretroviral experience and mutation analysis by age group for randomized study participants
| Characteristic | Low-dose TPV/r group |
High-dose TPV/r group |
Total |
|---|---|---|---|
| Total, n (%) | 58 (100) | 57 (100) | 115 (100) |
| Previous ARV medication experience (n)[median] | |||
| All age groups | 8 | 7 | 7 |
| 2 to <6 years | 3 | 4 | 3 |
| 6 to <12 years | 8 | 6 | 8 |
| 12 to 18 years | 10 | 11 | 10 |
| GSS [median (range)] | |||
| All age groups | 0.25 (0–2) | 0.25 (0–2.25) | 0.25 (0–2.25) |
| 2 to <6 years | 1.00 (0–2) | 0.25 (0–2) | 0.25 (0–2) |
| 6 to <12 years | 0.25 (0–2) | 0.25 (0–2.25) | 0.25 (0–2.25) |
| 12 to 18 years | 0.25 (0–2) | 0.13 (0–1.5) | 0.25 (0–2) |
| No. of protease gene mutations [median (range)] | |||
| All age groups | 13 (2–25) | 13 (2–26) | 13 (2–26) |
| 2 to <6 years | 10 (2–25) | 11 (4–16) | 10 (2–25) |
| 6 to <12 years | 14 (2–22) | 12 (3–26) | 13 (2–26) |
| 12 to 18 years | 17 (5–24) | 17 (2–25) | 17 (2–25) |
| TPV mutation score [median (range)] | |||
| All age groups | 3.0 (0–9) | 2.0 (0–9) | 3.0 (0–9) |
| 2 to <6 years | 2.0 (0–6) | 1.0 (0–5) | 1.0 (0–6) |
| 6 to <12 years | 4.0 (0–7) | 1.0 (0–5) | 2.5 (0–7) |
| 12 to 18 years | 3.5 (0–9) | 3.5 (0–9) | 3.5 (0–9) |
| LPV mutation score [median (range)] | |||
| All age groups | 4.0 (0–9) | 4.0 (0–9) | 4.0 (0–9) |
| 2 to <6 years | 2.0 (0–8) | 2.5 (1–6) | 2.0 (0–8) |
| 6 to <12 years | 5.0 (0–8) | 2.0 (0–9) | 4.5 (0–9) |
| 12 to 18 years | 5.5 (0–9) | 6.5 (0–9) | 6.0 (0–9) |
| Resistance to all PIs, n (%) | |||
| All age groups | 29 (50.0) | 28 (49.1) | 57 (49.6) |
| 2 to <6 years | 2 (15.4) | 3 (25.0) | 5 (20.0) |
| 6 to <12 years | 9 (47.4) | 9 (47.4) | 18 (47.4) |
| 12 to 18 years | 18 (69.2) | 16 (61.5) | 34 (65.4) |
Low-dose TPV/r = tipranavir 290 mg/m2 plus ritonavir 115 mg/m2
High-dose TPV/r = tipranavir 375 mg/m2 plus ritonavir 150 mg/m2
ARV = antiretroviral
GSS = genotypic sensitivity score
LPV = lopinavir
PI = protease inhibitor