TABLE 1.
Baseline patient characteristics by treatment group
| Characteristic | Value for patients exhibiting characteristica
|
Total patients (n = 140) | |||
|---|---|---|---|---|---|
| Caspofungin acetate, 35 mg (n = 34) | Caspofungin acetate, 50 mg (n = 34) | Caspofungin acetate, 70 mg (n = 37) | Amphotericin B, 0.5 mg/kg (n = 35) | ||
| Stratumb | |||||
| Esophageal (± oropharyngeal) | 21 (61.8) | 20 (58.8) | 24 (64.9) | 23 (65.7) | 88 (62.9) |
| Oropharyngeal (exclusively) | 13 (38.2) | 14 (41.2) | 13 (35.1) | 12 (34.3) | 52 (37.1) |
| Substratumc | |||||
| Unresponsive to fluconazole | 6 (17.6) | 3 (8.8) | 7 (18.9) | 5 (14.3) | 21 (15.0) |
| Responsive to fluconazoled | 28 (82.4) | 31 (91.2) | 30 (81.1) | 30 (85.7) | 119 (85.0) |
| Stratum-substratume | |||||
| 1 | 2 (5.9) | 1 (2.9) | 2 (5.4) | 1 (2.9) | 6 (4.3) |
| 2 | 11 (32.4) | 13 (38.2) | 11 (29.7) | 11 (31.4) | 46 (32.9) |
| 3 | 4 (11.8) | 2 (5.9) | 5 (13.5) | 4 (11.4) | 15 (10.7) |
| 4 | 17 (50.0) | 18 (52.9) | 19 (51.4) | 19 (54.3) | 73 (52.1) |
| HIV infection | |||||
| Positive | 32 (94.1) | 33 (97.1) | 37 (100.0) | 35 (100.0) | 137 (97.9) |
| Negative | 2 (5.9) | 1 (2.9) | 0 (0.0) | 0 (0.0) | 3 (2.1) |
| Baseline esophageal grade | |||||
| 1/2 | 1 (2.9) | 2 (5.9) | 2 (5.4) | 3 (8.6) | 8 (5.7) |
| 1 | 4 (11.8) | 0 (0.0) | 2 (5.4) | 1 (2.9) | 7 (5.0) |
| 2 | 3 (8.8) | 5 (14.7) | 7 (18.9) | 3 (8.6) | 18 (12.9) |
| 3 | 10 (29.4) | 11 (32.4) | 9 (24.3) | 12 (34.3) | 42 (30.0) |
| 4 | 2 (5.9) | 2 (5.9) | 4 (10.8) | 4 (11.4) | 12 (8.6) |
| Baseline oropharyngeal grade | |||||
| 1 | 6 (17.6) | 6 (17.6) | 2 (5.4) | 4 (11.4) | 18 (12.9) |
| 2 | 3 (8.8) | 8 (23.5) | 7 (18.9) | 4 (11.4) | 22 (15.7) |
| 3 | 4 (11.8) | 0 (0.0) | 4 (10.8) | 4 (11.4) | 12 (8.6) |
| CD4 countf | |||||
| No. of patients | 31 | 32 | 36 | 34 | 133 |
| Mean | 109.2 | 72.6 | 51.9 | 59.4 | 72.2 |
| SD | 198.1 | 99.8 | 102.4 | 65.9 | 124.9 |
| Median | 48.0 | 34.0 | 21.5 | 29.0 | 30.0 |
| Range | 2-879 | 0-405 | 0-561 | 0-260 | 0-879 |
Results are presented as number (percent) unless otherwise indicated.
Primary site of infection.
Prior response to fluconazole.
Includes patients not previously exposed to fluconazole or other azole antifungal agents.
Stratum-substratum categories: 1, oropharyngeal candidiasis alone and unresponsive to fluconazole; 2, oropharyngeal candidiasis alone and responsive to or not previously exposed to fluconazole; 3, esophageal candidiasis (with or without oropharyngeal candidiasis) and unresponsive to fluconazole; 4, esophageal candidiasis (with or without oropharyngeal candidiasis) and responsive or not previously exposed to fluconazole.
CD4 count tabulations include only those patients with HIV infection. Mean, standard deviation, median, and range are given as number of cells per cubic millimeter.