Table 1.
Baseline Characteristics
| Characteristic | Treatment Class | Total (N = 99) | |
|---|---|---|---|
| PI (n = 52) | NNRTI (n = 47) | ||
| Sex (n [%]) | |||
| Male | 26 (50) | 26 (55) | 52 (53) |
| Female | 26 (50) | 21 (45) | 47 (47) |
| Age (median [IQR]) (y) | 5.7 (3.3–13.5) | 6.6 (4.2–13.4) | 6.5 (3.7–13.4) |
| <3 y (n [%]) | 12 (23) | 10 (21) | 22 (22) |
| ≥3 y (n [%]) | 40 (77) | 37 (79) | 77 (78) |
| Race (n [%]) | |||
| White | 21 (40) | 16 (34) | 37 (37) |
| Black | 20 (39) | 23 (49) | 43 (43) |
| Other | 11 (21) | 8 (17) | 19 (19) |
| Country (n [%]) | |||
| Argentina | 2 (4) | 4 (9) | 6 (6) |
| Austria | 1 (2) | 1 (2) | 2 (2) |
| France | 6 (12) | 4 (9) | 10 (10) |
| Germany | 4 (8) | 4 (9) | 8 (8) |
| Italy | 4 (8) | 5 (11) | 9 (9) |
| Romania | 12 (23) | 8 (17) | 20 (20) |
| Spain | 1 (2) | 0 (0) | 1 (1) |
| UK/Ireland | 9 (17) | 7 (15) | 16 (16) |
| US/PACTG sites | 13 (25) | 14 (30) | 27 (27) |
| HIV RNA viral load (median [IQR]) (log10 copies/mL) | 4.9 (4.6–5.7) | 5.4 (4.5–5.6) | 5.1 (4.6–5.6) |
| Baseline CD4% (median [IQR]) | 16.0 (7.0–26.5) | 14.0 (6.0–17.5) | 15.5 (6.5–23.0) |
| NRTIs (backbone) (n [%]) | |||
| LMV ABC | 15 (29) | 17 (36) | 32 (32) |
| LMV ZDV | 18 (35) | 20 (43) | 38 (38) |
| LMV STV | 18 (35) | 8 (17) | 26 (26) |
| Other | 1 (2) | 2 (4) | 3 (3) |
| PIs (n [%]) | |||
| LPV/r | 29 (56) | 0 (0) | 29 (29) |
| NFV | 21 (40) | 0 (0) | 21 (21) |
| None | 2 (4) | 47 (100) | 49 (49) |
| NNRTIs (n [%]) | |||
| EFVa | 2 (4) | 33 (70) | 35 (35) |
| NVP | 0 (0) | 14 (30) | 14 (14) |
| None | 50 (96) | 0 (0) | 50 (51) |
Abbreviations: ABC, abacavir; EFV, efavirenz; HIV, human immunodeficiency virus; IQR, interquartile range; LMV, lamivudine; LPV/r, lopinavir/ritonavir; NFV, nelfinavir; NNRTI, nonnucleoside reverse-transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; NVP, nevirapine; PACTG, pediatric AIDS clinical trials group; PI, protease inhibitor; STV, stavudine; ZDV, zidovudine.
aTwo participants randomly assigned to the NNRTI arm and initially started on EFV were reassigned to receive LPV/r within the first 2 weeks and were included in the PI group for analysis.