Table 1. Baseline Characteristics.
| Main trial | Substudy | Substudy | Overall | |||
| CT | PTI | CT | PTI | p-value | p-value | |
| (n = 53) | (n = 56) | (n = 18) | (n = 18) | CT vs PTI | main trial vs substudy | |
| Male (%) | 22 (42%) | 27 (48%) | 9 (50%) | 10 (56%) | 0.7 | 0.4 |
| Age (years) | ||||||
| median [IQR] | 9.9 [6.4,12.3] | 9.0 [6.7,11.9] | 9.9 [5.8,11.6] | 9.0 [6.0,10.9] | 1.0 | 0.6 |
| ≥2 years to <7 years | 15 (28%) | 17 (30%) | 6 (33%) | 7 (39%) | ||
| ≥7 years to <11 years | 18 (34%) | 22 (40%) | 8 (44%) | 8 (44%) | 0.9 | 0.3 |
| ≥11 years to <16 years | 20 (38%) | 17 (31%) | 4 (22%) | 3 (17%) | ||
| CDC disease stage | ||||||
| % N/A/B/C | 17/23/26/34 | 20/34/28/18 | 1/4/7/6 | 3/4/8/3 | 0.6 | 0.4 |
| HIV-1 RNA: | ||||||
| ≥50 copies/ml at baselinea | 3 (6%) | 8 (14%) | 2 (11%) | 3 (17%) | 0.6 | 0.5 |
| CD4 parameters, median [IQR] | ||||||
| CD4% of total lymphocytes | 37 [34,40] | 37 [33,42] | 35 [33], [38] | 37 [33,44] | 0.1 | 1.0 |
| CD4 (cells/mm3) | 965 [741,1222] | 967 [844,1302] | 999 [786,1151] | 989 [860,1321] | 0.4 | 0.9 |
| CD8 parameters, median [IQR] | ||||||
| CD8% of total lymphocytes | 31 [27], [34] | 33 [26], [37] | 29 [25], [32] | 25 [23], [33] | 0.3 | 0.02 |
| CD8 (cells/mm3) | 790 [592,1020] | 871 [615,1070] | 765 [540,1010] | 643 [544,961] | 0.5 | 0.2 |
a
All children had HIV-1 RNA <50 copies/ml at screening and pre-screening. HIV-1 RNA was assumed to be at least 50 copies/ml at baseline for 11 children [six children (two CT and four PTI) <100 copies/ml, two children (one CT and one PTI) <200 copies/ml and three children (PTI) > = 200 copies/ml: range 240–2430 copies/ml. Note: chi-squared test and t-test were used to compare categorical and continuous characteristics respectively.
CT = continuous therapy; PTI = planned treatment interruption; IQR = interquartile range; CDC = Centers for Disease Control and Prevention.