Table 1.
Baseline characteristics of participants by randomized treatment arm
| LPV/r | NVP | Total | |
|---|---|---|---|
| Characteristic | (N=371) | (N=370) | (N=741) |
| Age (years) | |||
| Mean (SD) | 33(7) | 34(7) | 34(7) |
| Height (cm) | |||
| Mean (SD) | 160(6) | 159(6) | 160(6) |
| Weight (kg) | |||
| Mean (SD) | 60(12) | 60(13) | 60(13) |
| BMI (kg/m2) | |||
| Mean (SD) | 24(5) | 24(5) | 24(5) |
| HIV-1 RNA (log10 copies/mL) | |||
| Mean (SD) | 5.0(0.7) | 5.0(0.7) | 5.0(0.7) |
| CD4 count (cells/mm3) | |||
| Mean (SD) | 124(73) | 125(53) | 124(64) |
| Hemoglobin (g/dL) | |||
| Mean (SD) | 11.6(1.8) | 11.6(1.6) | 11.6(1.7) |
| Serum creatinine (mg/dL) | |||
| Mean (SD) | 0.71(0.21) | 0.70(0.15) | 0.71(0.18) |
| Serum creatinine grade, number (%)± | |||
| Normal | 368(99.2) | 368(99.5) | 736(99.3) |
| Mild (Grade 1) | 1(0.3) | 1(0.3) | 2(0.3) |
| Moderate (Grade 2) | 0 | 0 | 0 |
| Severe (Grade 3) | 2(0.5) | 0 | 2(0.3) |
| Potentially Life-threatening(Grade 4) | 0 | 1(0.3) | 1(0.1) |
| Creatinine Clearance (mL/min) | |||
| Mean (SD) | 112(34) | 113(37) | 112(35) |
| Single Dose NVP Exposure, number (%) | |||
| Yes | 121(32.6) | 121(32.7) | 242(32.7) |
| No | 250(67.3) | 249(67.3) | 499(67.3) |
SD: standard deviation; BMI: body mass index; NVP: nevirapine; ULN: Upper Limit of Normal
±
Subjects with baseline grade 3 and 4 events were excluded from renal analysis. Grade 1 (1.1–1.3 X ULN), Grade 2(1.4–1.8 x ULN), Grade 3 (1.9–3.4 x ULN), Grade 4 (>=3.5 x ULN)