Table 2. Baseline demographic, clinical and laboratory characteristics.
| TREATMENT GROUP (N) | 1200mg FCZ (N = 22) | 1600mg FCZ (N = 50) | 2000mg FCZ (N = 48) | AMB (N = 48) | p |
|---|---|---|---|---|---|
| Age (yrs) | 40.5 (36, 47) | 33.5 (28, 38) | 36.4 (29, 42) | 36.3 (31, 40) | 0.01* |
| Sex—M | 12 (54.5%) | 26 (52.0%) | 24 (50.0%) | 28 (58.3%) | 0.86 ** |
| BMI (kg/m 2 ) | 17.2 (15.6, 19.6) | 19.1 (17.1, 21.3) | 19.2 (17.4, 22.5) | 19.7 (17.0, 23.8) | 0.03 * |
| Weight (kg) | 46.5 (42.0, 52.2) | 50.3 (44.0, 63.0) | 54.8 (47.5, 59.1) | 54.0 (48.5, 62.0) | 0.01 * |
| Height (cm) | 163.0 (155.0, 169.0) | 162.7 (156.0, 171.1) | 166.5 (158.5, 172.5) | 167.3 (162.0, 171.0) | 0.10 * |
| CD4 count (cell/mm 3 ) | 20 (9, 55) | 25 (8, 75) | 28.0 (9, 63) | 26 (9, 58) | 0.82 * |
| HIV RNA (log10) (copies/mL) | 5.3 (5.1, 6.0) | 5.3 (5.0, 5.8) | 5.3 (4.7, 5.8) | 5.3 (4.4, 5.7) | 0.39 * |
| On ART † | 0 (0.0%) | 8 (16.0%) | 12 (25.0%) | 11 (22.9%) | - |
| OIs >0 | 10 (45.5%) | 18 (36.0%) | 20 (41.7%) | 20 (41.7%) | 0.87 ** |
| GCS <15 | 5 (22.7%) | 5 (10.0%) | 5 (10.6%) | 1 (2.1%) | 0.06 ** |
| Mini-Mental Status | 26 (23, 26) | 26 (21, 26) | 26 (20, 26) | 26 (24, 26) | 0.85 * |
| Opening Pressure (mm H 2 O) | 200 (105, 300) | 200 (150, 258) | 210 (150, 420) | 260 (140, 420) | 0.17 * |
| Albumin (g/dL) | 2.9 (2.6,3.3) | 3.2 (3.0,3.4) | 3.2 (2.7,3.6) | 3.9 (2.7,3.6) | 0.16 * |
| ALT (SGPT) | 19.3 (11.0,22.8) | 34.9 (14.9,33.0) | 29.4 (14.4,35.0) | 26.3 (13.5,33.5) | 0.15 * |
| Creatinine clearance (mL/min) | 95.6 (79.5,112.1) | 92.9 (75.0,105.7) | 95 (69.4,118.5) | 96.1 (80.0,116.6) | 0.60 * |
| CrAG titer | 756 (256, 8192) | 153.5 (32, 1024) | 512 (32, 4063) | 1024 (160, 4096) | 0.01 * |
| Crypto CFU (log10) | 5.2 (4.2, 6.0) | 5.0 (4.0, 5.4) | 4.4 (3.3, 5.4) | 4.7 (3.4, 5.3) | 0.27* |
Note: Median (IQR) for continuous, count (%) for categorical† Stage 1 did not include participants on ART at baseline, while Stage 2 did.
* Wilcoxon rank sum test
** Chi-square test