Table 1.
Characteristics of subjects on study at week 24 (randomization for Group 1)
| Characteristic | Total (N=286) | CD4% at Study Entry | P-Value1 | |||
|---|---|---|---|---|---|---|
| Group2: CD4%<1 5 (N=31) | Group1: CD4%≥15: 1-Dose (N=127) | Group1: CD4%≥15 : 2-Dose (N=128) | ||||
| Screening CD4%≥25 | 0 | 72 (57%) | 72 (56%) | >0.99 | ||
| Median CD4%* | 27 | 7 | 29 | 28 | 0.81 | |
| Male | 168 (59%) | 19 (61%) | 75 (59%) | 74 (58%) | 0.90 | |
| Age* (years) | Median | 18 | 19.7 | 17.8 | 17.8 | 0.80 |
| 11–15 | 103 (36%) | 7 (23%) | 45 (35%) | 51 (40%) | ||
| 16–19 | 84 (29%) | 9 (29%) | 39 (31%) | 36 (28%) | ||
| 20–24 | 95 (33%) | 14 (45%) | 42 (33%) | 39 (30%) | ||
| 25+ | 4 (1%) | 1 (3%) | 1 (1%) | 2 (2%) | ||
| Black | 146 (51%) | 15 (48%) | 62 (49%) | 69 (54%) | 0.29 | |
| Latino | 107 (37%) | 15 (48%) | 47 (37%) | 45 (35%) | 0.89 | |
| HIV RNA<400 copies/mL* | 146 | 6 (19%) | 74 (58%) | 66 (52%) | 0.31 | |
| CDC Class C* | 69 (%) | 9 (29%) | 30 (24%) | 30 (23%) | 0.93 | |
| On HAART* | 208 | 19 (61%) | 95 (75%) | 94 (73%) | 0.89 | |
CDC= Centers for Disease Control and Prevention; HAART=highly active antiretroviral therapy.
1
– P-value for comparison between 1-dose and 2-dose arms, using Wilcoxon test for age, and Fisher exact test for all other characteristics.
*
at Step 2 entry