Table 1.
Baseline Characteristics
| Treatment Group, Total N = 40 | ||||
|---|---|---|---|---|
| Characteristic | Dose Group 1 (20 mg/kg) (N = 13) | Dose Group 2 (40 mg/kg) (N = 14) | Dose Group 3a (40 mg/kg + 20 mg/kg Monthly) (N = 13) | |
| Gender | M | 8 (62%) | 6 (43%) | 8 (62%) |
| Race | Black | 6 (46%) | 11 (79%) | 13 (100%) |
| White | 6 (46%) | 2 (14%) | 0 (0%) | |
| Unknown | 1 (8%) | 1 (7%) | 0 (0%) | |
| Ethnicity | Hispanic or Latino | 5 (38%) | 4 (29%) | 0 (0%) |
| Infant ART | 3TC, ZDV | 1 (8%) | 0 (0%) | 0 (0%) |
| 3TC, ZDV, NFV | 1 (8%) | 0 (0%) | 0 (0%) | |
| 3TC, ZDV, NVP | 2 (15%) | 5 (36%) | 0 (0%) | |
| NVP | 0 (0%) | 1 (7%) | 12 (92%) | |
| ZDV | 4 (31%) | 4 (29%) | 0 (0%) | |
| ZDV, NVP | 5 (38%) | 4 (29%) | 1 (8%) | |
| Age (days) at VRC01 administration | Mean (s.d.) | 1.5 (1.1) | 1.9 (0.9) | 2.7 (1.4) |
| Median (Q1, Q3) | 2 (1, 2) | 2 (1, 3) | 2 (2, 3) | |
| Min, Max | 0, 3 | 0, 3 | 1, 5 | |
| Weight at birth (grams) | Mean (s.d.) | 3185.4 (703.6) | 3134.9 (265.7) | 3055.0 (605.6) |
| Median (Q1, Q3) | 3045 (2676, 3380) | 3160 (2900, 3386) | 2860 (2670, 3380) | |
| Min, Max | 2330, 4675 | 2609, 3580 | 2330, 4320 | |
| Enrollment site | African | 1 (8%) | 5 (36%) | 13 (100%) |
| United States | 12 (92%) | 9 (64%) | 0 (0%) | |
Abbreviations: ART, antiretroviral therapy; Max, maximum; Min, minimum; NFV nelfinavir; NVP nevirapine; s.d., standard deviation; ZDV zidovudine; 3TC lamivudine.
aDose Group 3 inclusion criteria required breastfeeding.