TABLE 1.
Baseline characteristicsa
| Characteristic | Phase IA |
Phase IB (1.5 g) | ||
|---|---|---|---|---|
| Cohort 1 (1.0 g) | Cohort 2 (1.5 g) | Cohort 3 (2.0 g) | ||
| Demographic | ||||
| Median (IQR) age (yr) | 33 (30, 44) | 39 (30, 43) | 42 (35, 44) | 34 (31, 40) |
| No. (%) of female participants | 4 (44.4) | 2 (22.2) | 5 (55.6) | 5 (55.6) |
| Median (IQR) ht (cm) | 165.8 (158.2, 168.5) | 165.7 (163.3, 167.2) | 166.0 (153.2, 168.8) | 164.2 (156.4, 165.8) |
| Median (IQR) wt (kg) | 63.5 (60.5, 68.5) | 57.5 (55.5, 68.0) | 75.0 (65.5, 78.0) | 69.5 (61.5, 79.8) |
| Median (IQR) value for the following vital signs: | ||||
| Systolic BP (mm Hg) | 108 (104, 112) | 124 (120, 132) | 112 (107, 125) | 127 (113, 136) |
| Diastolic BP (mm Hg) | 70 (60, 72) | 79 (73, 88) | 73 (68, 83) | 78 (69, 82) |
| Pulse (bpm) | 69 (64, 74) | 70 (69, 79) | 65 (60, 78) | 74 (66, 83) |
| HIV infection history | ||||
| No. (%) of HIV-positive participants | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) |
| No. (%) of participants currently on ART | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) |
| Median (IQR) time (mo) on ART | 41.9 (10.7, 43.2) | 28.6 (16.1, 52.4) | 42.0 (19.7, 47.0) | 41.4 (18.6, 44.6) |
| CM history | ||||
| No. (%) of participants with previous blood CrAg screen | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) |
| No. (%) of participants with history of CM | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) |
| Median (IQR) time (mo) since last diagnosis | 45.3 (44.3, 46.2) | 48.1 (41.4, 51.9) | 49.1 (44.7, 51.1) | 48.5 (47.8, 50.6) |
| No. (%) of participants with prior i.v. AMB therapy | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) |
| No. (%) of participants with other medical conditions/medications | ||||
| Currently with another medical condition | 1 (11.1) | 2 (22.2) | 0 (0.0) | 0 (0.0) |
| Currently taking fluconazole | 2 (22.2) | 5 (55.6) | 3 (33.3) | 2 (22.2) |
| Currently taking co-trimoxazole | 3 (33.3) | 1 (11.1) | 3 (33.3) | 2 (22.2) |
a
Nine participants were enrolled in each cohort. Abbreviations: BP, blood pressure; ART, antiretroviral therapy; bpm, numbers of beats per minute; CrAg, cryptococcal antigen; CM, cryptococcal meningitis.