Table 1.
Baseline Characteristics of Participants
| Characteristic | Part A CFZ Group (n = 12) | Part A Placebo Group (n = 10) | Part B CFZ Group (n = 11) |
|---|---|---|---|
| Age, y | 39.8 (± 7.8) | 39.1 (± 12.0) | 44.1 (± 9.6) |
| Male sex (%) | 8 (67) | 2 (20) | 7 (64) |
| Body mass index, kg/m2 | 16.3 (± 1.7) | 18.0 (± 3.1) | 18.9 (± 1.4) |
| Pulse rate, beats/min | 90.9 (± 12.4) | 95.9 (± 14.9) | 78.1 (± 6.7) |
| Systolic blood pressure, mm Hg | 99.3 (± 15.0) | 106.4 (± 16.5) | 116.5 (± 11.8) |
| Diastolic blood pressure, mm Hg | 68.3 (± 10.1) | 71.2 (± 8.8) | 75.7 (± 12.3) |
| Hemoglobin, g/dL | 10.6 (± 2.2) | 10.8 (± 2.8) | 14.0 (± 1.3) |
| Hematocrit, % | 32.3 (± 6.5) | 32.6 (± 8.7) | 42.3 (± 3.6) |
| White blood cells, 109/L | 2.9 (± 1.4) | 3.8 (± 2.8) | 5.0 (± 1.7) |
| Neutrophils, 109/L | 1.6 (± 0.9) | 2.1 (± 2.1) | 2.5 (± (± 1.2) |
| Lymphocytes, 109/L | 0.8 (± 0.5) | 1.1 (± 0.7) | 2.0 (± 0.8) |
| CD4 absolute, cells/µL | |||
| Mean (± standard deviation) | 25.3 (± 24.4) | 170.4 (± 321.7) | 422.0 (± 231.3) |
| Median (interquartile range) | 23.0 (8.0–32.0) | 22.5 (17.0–86.0) | 361.0 (216.0–634.0) |
| Human immunodeficiency virus viral load, copies/µL | 241 981.5 (± 262 806.03) | 679 025.13 (± 929 116.49) | 257.5 (± 805.7) |
| Antiretroviral therapy duration, days | 1424 (± 1547.6) | 2011 (± 1409.3) | 1265 (±1810.3) |
| Blood urea nitrogen, mmol/L | 4.9 (± 2.5) | 3.9 (± 1.1) | 3.8 (± 1.0) |
| Creatinine, µmol/L | 82.0 (± 37.2) | 56.0 (± 15.9) | 65.4 (± 14.0) |
| Alanine aminotransferase, IU/L | 34.0 (± 20.3) | 40.3 (± 19.5) | 38.9 (± 21.4) |
| Aspartate aminotransferase, IU/L | 50.6 (± 16.4) | 63.0 (± 30.4) | 50.7 (± 18.3) |
| Electrocardiogram | |||
| Normal (%) | 11 (92) | 10 (100) | 11 (100) |
| Abnormal, not clinically significant (%) | 1 (8) | 0 (0) | 0 (0) |
| QTc interval, ms | 421.7 (± 14.2) | 418.3 (± 17.0) | 409.7 (± 21.6) |
| Cryptosporidium spp. (%) | |||
| C. parvum | 7 (58%) | 4 (40%) | N/A |
| C. hominis | 2 (17%) | 1 (10%) | N/A |
| C. meleagridis | 1 (8%) | 3 (30%) | N/A |
| C. viatorum | 1 (8%) | 0 (0%) | N/A |
| Unknowna | 1 (8%) | 2 (20%) | N/A |
| Copathogens detected at diarrheagenic amount (%) | 8 (67) | 3 (30) | N/A |
| Diarrhea duration,b days | 17 (± 7.6) | 34 (± 57) | N/A |
| Stool enzyme-linked immunosorbent assay positivity (D-1, %) | 7 (58) | 2 (20) | N/A |
| Log number of Cryptosporidium shed in first collected stool of day, Cryptosporidium per gram stool (D-1) | 13.9 (± 2.7) | 15.0 (± 2.2) | N/A |
| Total daily Cryptosporidium shedding, Cryptosporidium per gram stool (D-1) | 22.3 (± 2.9) | 22.1 (± 3.2) | N/A |
| Total stool weight, g (D-1) | 320.3 (± 214.6) | 245.8 (± 299.4) | N/A |
| Most severe diarrhea severity gradec (mild) | 9 (75%) | 3 (30%) | N/A |
| Stool consistency severity grade ≥ 3 (D-1, %) | 9 (75) | 6 (67) | N/A |
| Number of diarrheal episodes,c D1 | 1.3 (± 1.1) | 0.8 (± 1.3) | N/A |
All values are mean (± standard deviation), unless otherwise listed.
Abbreviations: CFZ, clofazimine; D, day; N/A, not available.
aFailed to amplify on sequencing of 18s and gp60.
bParticipants with diarrhea duration entries “ >2 weeks” were treated as 21 days for calculations of summary statistics.
cObserved over the first 24-hour dosing interval after the first study dose.