Table 1.
Baseline characteristics by treatment group
| All Subjects (N=165) | NucleomaxX (N=83) | Placebo (N=82) | |||
|---|---|---|---|---|---|
| Gender | Male | 150 (91%) | 75 (90%) | 75 (91%) | |
| Female | 15 (9%) | 8 (10%) | 7 (9%) | ||
| Race/Ethnicity | White | 102 (62%) | 50 (60%) | 52 (63%) | |
| Black | 25 (15%) | 11 (13%) | 14 (17%) | ||
| Hispanic | 27 (16%) | 15 (18%) | 12 (15%) | ||
| Asian | 4 (2%) | 3 (4%) | 1 (1%) | ||
| American Indian | 5 (3%) | 3 (4%) | 2 (2%) | ||
| Other/Invalid | 1 (1%) | 1 (1%) | 0 (0%) | ||
| Missing/Unknown | 1 (1%) | 0 (0%) | 1 (1%) | ||
| IV Drug Use at Baseline | Never | 139 (84%) | 72 (87%) | 67 (82%) | |
| Currently | 1 (1%) | 1 (1%) | 0 (0%) | ||
| Previously | 25 (15%) | 10 (12%) | 15 (18%) | ||
| Age at Baseline (Yrs) | Median (Q1, Q3) | 49 (44, 53) | 47 (43, 54) | 49 (44, 53) | |
| 30–39 | 19 (12%) | 9 (11%) | 10 (12%) | ||
| 40–49 | 70 (42%) | 38 (46%) | 32 (39%) | ||
| 50–59 | 66 (40%) | 28 (34%) | 38 (46%) | ||
| Over 60 | 10 (6%) | 8 (10%) | 2 (2%) | ||
| Stratification Factor | AZT-containing | 126 (76%) | 63 (76%) | 63 (77%) | |
| D4T-containing | 39 (24%) | 20 (24%) | 19 (23%) | ||
| CD4 Count | Median (Q1, Q3) | 506 (353, 724) | 506 (353, 724) | 504 (376, 709) | |
| < 100 | 1 (1%) | 0 (0%) | 1 (1%) | ||
| 100–199 | 8 (5%) | 6 (7%) | 2 (2%) | ||
| 200–299 | 14 (8%) | 7 (8%) | 7 (9%) | ||
| 300–500 | 55 (33%) | 26 (31%) | 29 (35%) | ||
| > 500 | 82 (50%) | 41 (49%) | 41 (50%) | ||
| Missing/Unknown | 5 (3%) | 3 (4%) | 2 (2%) | ||
| HIV-1 R N A ≤50 cp/mL | 134 (81%) | 70 (84%) | 64 (78%) | ||
| BMI (kg/m2) | N, Median (Q1, Q3) | 161, 23.9 (21.9, 26.0) | 81, 23.6 (21.4, 25.9) | 80, 24.3 (22.2, 26.5) | |
| Limb fat (grams) | N, Median (Q1, Q3) | 165, 3037(2002, 4403) | 83, 3149 (1833, 4210) | 82, 2995 (2082, 4847) | |
Note: No statistically significant difference for baseline characteristics between the study arms; Q1=first quartile, Q3=third quartile