Table 1.
Characteristics at Enrollment
| Factor | Standard Prophylaxis (n = 899) |
Enhanced Prophylaxis (n = 906) |
All (N = 1805) |
|
|---|---|---|---|---|
| Country | Kenya | 174 (19.4) | 177 (19.5) | 351 (19.4) |
| Malawi | 128 (14.2) | 127 (14.0) | 255 (14.1) | |
| Uganda | 313 (34.8) | 317 (35.0) | 630 (34.9) | |
| Zimbabwe | 284 (31.6) | 285 (31.5) | 569 (31.5) | |
| Male sex | 484 (53.8) | 477 (52.6) | 961 (53.2) | |
| Age, y | 36 (30–42) [range, 5–78] | 36 (29–42) [range, 6–71] | 36 (29–42) [range, 5–78] | |
| Age 5–17 y | 33 (3.7) | 39 (4.3) | 72 (4.0) | |
| WHO stage | 1 | 153 (17.0) | 147 (16.2) | 300 (16.6) |
| 2 | 265 (29.5) | 289 (31.9) | 554 (30.7) | |
| 3 | 349 (38.8) | 342 (37.7) | 691 (38.3) | |
| 4 | 132 (14.7) | 128 (14.1) | 260 (14.4) | |
| CD4 counta, cells/µL | 36 (16–60) | 38 (16–64) | 37 (16–63) | |
| CD8 count, cells/µL (n = 1693) | 473 (302–734) | 497 (317–721) | 482 (308–726) | |
| HIV viral load, copies/mL (n = 1792) | 250000 (92460–544240) | 246130 (97620–654160) | 249770 (95540–604960) | |
| HIV viral load ≥100000 copies/mL | 655/893 (73.3) | 671/899 (74.6) | 1326/1792 (74.0) | |
| BMI, kg/m2 (n = 1797) | 19.3 (17.4–21.5) | 19.1 (17.1–21.3) | 19.2 (17.2–21.4) | |
| Hemoglobin, g/dL (n = 1800) | 11.2 (9.6–12.7) | 11.1 (9.5–12.8) | 11.2 (9.6–12.7) | |
| Creatinine clearanceb, mL/min (n = 1793) | 97.1 (77.8–120.1) | 97.3 (76.6–121.9) | 97.3 (77.3–121.1) | |
| Albumin, g/L (n = 1751) | 35 (30–40) | 35 (30–40) | 35 (30–40) | |
| Bilirubin, µmol/L (n = 1768) | 6.0 (3.9–8.4) | 6.0 (3.8–9.0) | 6.0 (3.8–8.9) | |
| WBC count, 109/L (n = 1800) | 3.6 (2.7–4.7) | 3.5 (2.7–4.7) | 3.5 (2.7–4.7) | |
| Lymphocyte count, 109/L (n = 1790) | 0.9 (0.7–1.3) | 1.0 (0.7–1.4) | 1.0 (0.7–1.4) | |
| Neutrophil count, 109/L (n = 1783) | 1.8 (1.2–2.6) | 1.7 (1.2–2.5) | 1.7 (1.2–2.6) | |
| Platelet count, 109/L (n = 1789) | 252 (184–333) | 252 (183–352) | 252 (183–342) | |
| Water source (n = 1761) | ||||
| Protected well | 327 (37.3) | 296 (33.5) | 623 (35.4) | |
| Domestic tap: private standpipe | 246 (28.1) | 258 (29.2) | 504 (28.6) | |
| Domestic tap: communal standpipe | 98 (11.2) | 89 (10.1) | 187 (10.6) | |
| Communal tap | 119 (13.6) | 136 (15.4) | 255 (14.5) | |
| Lake/river/stream | 32 (3.6) | 41 (4.6) | 73 (4.1) | |
| Unprotected well | 55 (6.3) | 64 (7.2) | 119 (6.8) | |
| Household toilet type (n = 1794) | ||||
| Pit/latrine | 635 (70.6) | 616 (68.8) | 1251 (69.7) | |
| Flush | 264 (29.4) | 279 (31.2) | 543 (30.3) | |
Data are presented as No. (%) or median (interquartile range).
Abbreviations: BMI, body mass index; HIV, human immunodeficiency virus; WBC, white blood cell; WHO, World Health Organization.
aMean of screening and enrollment values. Eligibility required screening CD4 count to be <100 cells/µL, so baseline could be ≥100 cells/µL depending on the CD4 at enrollment.
bEstimated using Cockcroft-Gault, normalized to 1.73 m2.