Table 1.
Selected Baseline Characteristics of the Participants in Trial 1.*
| Characteristic | Nevirapine (N = 121) | Ritonavir-Boosted Lopinavir (N = 120) | Total (N = 241) |
|---|---|---|---|
| Age at randomization — yr | |||
| Median | 30 | 31 | 31 |
| 10th–90th percentile | 24–37 | 24–38 | 24–37 |
| Black race — no. (%)† | 121 (100) | 120 (100) | 241 (100) |
| CD4+ count at baseline | |||
| Median — cells/mm3 | 141 | 138 | 139 |
| 10th–90th percentile — cells/mm3 | 47–202 | 55–212 | 48–208 |
| <50 cells/mm3 — no. (%) | 14 (12) | 11 (9) | 25 (10) |
| HIV-1 RNA | |||
| Median — log10 copies/ml | 5.20 | 5.14 | 5.15 |
| 10th–90th percentile — log10 copies/ml | 4.26–5.84 | 4.19–5.88 | 4.24–5.88 |
| ≥750,000 copies/ml — no. (%) | 11 (9) | 15 (12) | 26 (11) |
| WHO HIV clinical stage — no. (%) | |||
| I | 44 (36) | 56 (47) | 100 (41) |
| II | 42 (35) | 38 (32) | 80 (33) |
| III | 30 (25) | 25 (21) | 55 (23) |
| IV | 5 (4) | 1 (1) | 6 (2) |
| Hepatitis B surface antigen | |||
| Positive — no. (%) | 9 (8) | 5 (4) | 14 (6) |
| Not determined — no. | 2 | 0 | 2 |
| Interval since most recent exposure to single-dose NVP | |||
| Median — mo | 16 | 17 | 17 |
| 10th–90th percentile — mo | 7–49 | 7–41 | 7–45 |
| ≥6 to <12 mo — no. (%) | 41 (34) | 37 (31) | 78 (32) |
| ≥12 to <24 mo — no. (%) | 46 (38) | 52 (43) | 98 (41) |
| ≥24 mo — no. (%) | 34 (28) | 31 (26) | 65 (27) |
| No. of previous exposures to single-dose NVP — no. (%) | |||
| 1 | 115 (95) | 114 (95) | 229 (95) |
| 2 | 6 (5) | 4 (3) | 10 (4) |
| 3 | 0 | 2 (2) | 2 (1) |
| Self-reported prior receipt of single-dose NVP — no. (%) | 121 (100) | 120 (100) | 241 (100) |
| Written documentation of prior nevirapine exposure — no. (%) | 86 (71) | 90 (75) | 176 (73) |
| Previous zidovudine exposure — no. (%) | 13 (11) | 12 (10) | 25 (10) |
| HIV subtype — no. (%) | |||
| A1 | 18 (15) | 15 (13) | 33 (14) |
| C | 87 (73) | 86 (72) | 173 (72) |
| D | 6 (5) | 9 (8) | 15 (6) |
| A2D | 1 (1) | 0 | 1 (0.4) |
| Complex recombination | 8 (7) | 9 (8) | 17 (7) |
| Test result not available — no. | 1 | 1 | 2 |
HIV denotes human immunodeficiency virus, NVP nevirapine, and WHO World Health Organization.
Race was reported by the investigators.