Table 1.
Patient characteristics
| Randomized to SOC alonea | Randomized to SOC, then added mefloquine at week 4 | Randomized to SOC, then added mefloquine at week 8 | Randomized to mefloquine + SOC | Total | ||
|---|---|---|---|---|---|---|
| Number of patients dosed | 7 | 5 | 5 | 20 | 37 | |
| Disease history, n (%) | HAART naïve | 3 (43) | 5 (100) | 3 (60) | 13 (65) | 24 (65) |
| History of HAART | 1 (14) | 0 | 1 (20) | 3 (15) | 5 (14) | |
| HIV negative | 3 (43) | 0 | 1 (20) | 4 (20) | 8 (22) | |
| JCV DNA titer (in CSF) at screening (copies/mL), n (%) | ≤50 | 0 | 0 | 0 | 4 (20)a | 4 (11)a |
| >50 | 7 (100) | 5 (100) | 5 (100) | 15 (75) | 32 (86) | |
| Missing | 0 | 0 | 0 | 1 (5) | 1 (3) | |
| Gender male, n (%) | Male | 6 (86) | 3 (60) | 3 (60) | 15 (75) | 27 (73) |
| Race, n (%) | Black or African American | 1 (14) | 2 (40) | 2 (40) | 4 (20) | 9 (24) |
| White | 6 (86) | 3 (60) | 3 (60) | 16 (80) | 28 (76) | |
| Age (years), mean (SD) | 48.7 (20.56) | 41.6 (11.37) | 47.4 (10.06) | 48.1 (9.40) | 47.2 (12.16) | |
| Weight (kg), mean (SD) | 71.31 (14.83) | 60.12 (12.75) | 75.54 (22.88) | 65.71 (15.52) | 67.34 (16.16) | |
HAART highly active antiretroviral therapy, HIV human immunodeficiency virus, JCV JC virus, SD standard deviation, SOC standard of care
All patients (n = 7) in the “randomized to SOC alone” column discontinued study treatment; of the remaining patients, those who were not randomized to receive SOC + mefloquine at the start of the study opted to be treated with mefloquine at week 4 or week 8. No patients remained on SOC alone throughout the study
aPatients enrolled based on local laboratory data; in some instances, the results were not replicated by the central laboratory