Table 1.
Baseline Demographics
| Characteristic | ITT, Maintenance-Exposed, Randomized Population | Extension-Switch Population | ||
|---|---|---|---|---|
| Q8W IM | Q4W IM | Q8W IM | Q4W IM | |
| (n = 115) | (n = 115) | (n = 34) | (n = 10) | |
| Age, y, median (range) | 34 (20–64) | 36 (19–62) | 36 (19–56) | 41 (21–56) |
| Reported gender, No. (%) | ||||
| Female | 8 (7) | 6 (5) | 6 (18) | 2 (20) |
| Male | 107 (93) | 109 (95) | 28 (82) | 8 (80) |
| BMI, kg/m2, median (range) | 24 (19–35) | 24 (17–37) | 24 (20–62) | 24 (19–30) |
| Race, No. (%) | ||||
| White | 93 (81) | 94 (82) | 24 (71) | 6 (60) |
| Black/African American | 17 (15) | 12 (10) | 10 (29) | 3 (30) |
| American Indian/Alaska Native | 0 | 8 (7) | 0 | 1 (10) |
| Other | 5 (4) | 1 (<1) | 0 | 0 |
| Baseline CD4+ cell count, cells/µL, median (IQR) | 449 (343–618)a | 499 (359–624)a | 988 (747–1093)b | 754 (644–962)b |
| Baseline HIV-1 RNA, log10 copies/mL, median (IQR) | 4.42 (4.05–4.80)a | 4.46 (4.00–4.97)a | 1.59 (1.59–1.59)b,c | 1.59 (1.59–1.59)b,c |
Abbreviations: BMI, body mass index; HIV-1, human immunodeficiency virus type 1; IM, intramuscular; IQR, interquartile range; ITT, intention to treat; Q4W, every 4 weeks; Q8W, every 8 weeks.
aBaseline is at week –20.
bExtension baseline is at week 100.
cAll participants had HIV-1 RNA <50 copies/mL at extension baseline.