Table 1.
Baseline Characteristics of Study Participants and Historical Controls
| Safety Population (N = 62) | Per-protocol Population (N = 42) | Historical Controls (N = 14) | Per-protocol Population vs Historical Controls, P Value | |
|---|---|---|---|---|
| Age, years | 32 (27, 37) | 32 (27, 35) | 33 (25, 37) | .67 |
| 20–29 | 24 (39) | 17 (40) | 4 (29) | .77 |
| 30–39 | 25 (40) | 19 (45) | 8 (57) | |
| 40–49 | 13 (21) | 6 (14) | 2 (14) | |
| African race or African American | 62 (100) | 42 (100) | 11 (79) | .013 |
| Injection drug use | 0 (0) | 0 (0) | 1 (7) | .003 |
| Weight, kg | 56.0 (49.0, 63.5) | 53.8 (47.8, 61.0) | 67.9 (52.3, 71.7) | .012 |
| Body mass index, kg/m2 | 20.8 (18.9, 36.1) | 20.4 (18.7, 24.4) | 23.3 (19.6, 27.0) | .19 |
| HIV RNA <400 copies/mL | 52 (84) | 36 (86) | 2 (15) | <.001 |
| CD4, cells/mm3 | 407 (209, 644) | 414 (226, 638) | 704 (625, 963) | .001 |
| <50 | 3 (5) | 1 (2) | 0 (0) | .18 |
| 50–199 | 12 (19) | 8 (19) | 0 (0) | |
| 200–349 | 11 (18) | 7 (17) | 1 (7) | |
| ≥350 | 36 (58) | 26 (62) | 13 (93) | |
| Enrollment by country | <.001 | |||
| South Africa | 35 (56) | 20 (48) | 0 (0) | |
| Kenya | 12 (19) | 10 (24) | 0 (0) | |
| Botswana | 7 (11) | 6 (14) | 0 (0) | |
| Zimbabwe | 8 (13) | 6 (14) | 0 (0) | |
| United States | 0 (0) | 0 (0) | 14 (100) |
Data are presented as no. (%) or median (IQR) unless otherwise indicated. P values are from the Wilcoxon test (continuous variables) and Fisher’s exact test (categorical variables). Abbreviations: HIV, human immunodeficiency virus; IQR, interquartile range.