TABLE 1.

Summary of demographics and baseline characteristics of children enrolled

Demographic or baseline characteristic	Overall (n = 25)	Cohort 2 (n = 2)	Cohort 3 (n = 8)	Cohort 4 (n = 8)	Cohort 5 (n = 7)
Gender (n [%])
Female	13 (52)	0 (0)	5 (63)	4 (50)	4 (57)
Male	12 (48)	2 (100)	3 (38)	4 (50)	3 (43)
Ethnic origin (n [%])
Black	20 (80)	2 (100)	7 (88)	7 (88)	4 (57)
Caucasian	1 (4)	0 (0)	0 (0)	1 (13)	0 (0)
Hispanic	4 (16)	0 (0)	1 (13)	0 (0)	3 (43)
Age (years)
Mean ± SD	8.5 ± 4.9	1.9 ± 0.1	4.3 ± 1.2	8.8 ± 1.6	14.9 ± 1.9
Median	7.6	1.9	4.1	8.7	15.4
Min., max.	1.8, 17.8	1.8, 1.9	2.3, 5.7	6.6, 10.7	13.0, 17.8
Body wt (kg)
Mean ± SD	32.5 ± 19.5	13.2 ± 1.1	16.5 ± 4.8	31.2 ± 8.3	57.8 ± 14.0
Median	24.5	13.2	15.0	30.5	57.9
Min., max.	10.2, 76.0	12.4, 13.9	10.2, 24.5	21.5, 43.8	35.4, 76.0
Body surface area (m2)
Mean ± SD	1.04 ± 0.42	0.56 ± 0.04	0.68 ± 0.14	1.07 ± 0.19	1.57 ± 0.20
Median	0.92	0.56	0.65	1.06	1.58
Min., max.	0.48, 1.86	0.53, 0.59	0.48, 0.89	0.84, 1.38	1.21, 1.86
Estimated CLcr (ml/min)
Mean ± SD	135 ± 84	74 ± 21	89 ± 39	131 ± 53	210 ± 110
Median	120	74	75	126	177
Min., max.	41, 447	60, 89	41, 165	64, 236	104, 447
Estimated CLcr (ml/min/1.73 m2)
Mean ± SD	225 ± 92	227 ± 47	230 ± 103	220 ± 106	224 ± 88
Median	199	227	200	199	199
Min., max.	120, 429	194, 261	145, 392	120, 429	149, 416
CD4+ cell count (cells/mm3)
Mean ± SD	730 ± 479	1636 ± 754	886 ± 384	571 ± 308	475 ± 353
Median	716	1,636	904	578	380
Min., max.	20, 2,169	1,103, 2,169	218, 1,479	211, 1,153	20, 956
Plasma HIV-1 RNA (log10 copies/ml)
Mean ± SD	3.8 ± 1.0	3.8 ± 0.7	4.0 ± 1.0	3.2 ± 0.7	4.2 ± 1.1
Median	3.7	3.8	4.1	2.9	4.6
Min., max	<2.6, 5.4	3.3, 4.3	<2.6, 5.3	<2.6, 4.3	<2.6, 5.4