Table 1. Baseline demographic and clinical characteristics of children who interrupted treatment with a nevirapine (NVP)– or efavirenz (EFV)–containing HAART regimen.
| Variable | NVP group (n = 20) |
EFV group (n = 15) |
All patients (n = 35) |
|---|---|---|---|
| Sex | |||
| Male | 9 (45) | 7 (47) | 16 (46) |
| Female | 11 (55) | 8 (53) | 19 (54) |
| Ethnicity | |||
| White | 5 (25) | 3 (20) | 8 (23) |
| Black | 5 (25) | 6 (40) | 11 (31) |
| Asian | 8 (40) | 3 (20) | 11 (31) |
| Mixed | 2 (10) | 3 (20) | 5 (14) |
| Age, median years (range) | 8.3 (3.6–15.9) | 9.4 (5.0–15.0) | 8.9 (3.6–15.9) |
| HIV RNA level <50 copies/mL | 17 (85) | 11a (79) | 28a (82) |
| CD4 cell count, median cells/μL (range) | 1033b (531–2100) | 919 (487–2646) | 1026b (487–2646) |
| CD4 cell percentage, median % (range) | 38b (29–53) | 36 (24–42) | 38b (24–53) |
| Previous ART exposure | |||
| All 3 main classes | 5 (25) | 5 (33) | 10 (29) |
| NRTI plus NNRTI | 15 (75) | 10 (67) | 25 (71) |
| ART drugs received, median no. (range) | |||
| All 3 main classes | 4 (3–8) | 4 (3–8) | 4 (3–8) |
| NRTIs | 2.5 (2–4) | 3 (2–5) | 3 (2–5) |
| NNRTIs | 1 (1–2) | 1 (1–2) | 1 (1–2) |
| PIs | 0 (0–3) | 0 (0–2) | 0 (0–3) |
| Cumulative ART exposure, median years (range) | |||
| All ART drugs | 5.2 (1.7–15.3) | 6.1 (2.7–10.8) | 5.4 (1.7–15.3) |
| NRTIs | 5.2 (1.7–11.6) | 6.1 (2.7–10.8) | 5.4 (1.7–11.6) |
| NNRTIs | 4.0 (1.7–7.7) | 3.7 (1.9–7.9) | 3.7 (1.7–7.9) |
| PIs | 0 (0–8.5) | 0 (0–6.3) | 0 (0–8.5) |
NOTE. Data are no. (%) of patients, unless otherwise indicated. Baseline characteristics are given at the time of randomization except for laboratory measurements, which are those measurements recorded nearest to or on (but not after) the day on which the NNRTI was stopped (day 0). ART, antiretroviral therapy; NNRTI, nonnucleoside reverse-transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; PI, protease inhibitor.
a
Data on HIV RNA level at day 0 was unavailable for 1 child; percentages are for children with available data.
b
CD4 cell count and CD4 cell percentage data at day 0 were unavailable for 1 child; percentages are for children with available data.