Table 1.
Characteristics at Antiretroviral Therapy Initiation
| Characteristic | Died Before 48 wk (n = 225) | Last Seen Alive (n = 1580) | All Participants (N = 1805) | Univariable P Valuea |
|---|---|---|---|---|
| Male sex | 109 (48) | 852 (54) | 961 (53) | .12 |
| Age, y | 37 (30–44) | 36 (29–41) | 36 (29–42) | .005 |
| Age 5–17 y | 4 (2) | 68 (4) | 72 (4) | |
| Center | <.001 | |||
| Blantyre, Malawi | 25 (11) | 230 (15) | 255 (14) | |
| Harare, Zimbabwe | 51 (23) | 518 (33) | 569 (32) | |
| Kilifi, Kenya | 29 (13) | 114 (7) | 143 (8) | |
| Eldoret, Kenya | 14 (6) | 194 (12) | 208 (12) | |
| Fort Portal, Uganda | 28 (12) | 114 (7) | 142 (8) | |
| Mbale, Uganda | 25 (11) | 94 (6) | 119 (7) | |
| Mbarara, Uganda | 26 (12) | 203 (13) | 229 (13) | |
| Gulu, Uganda | 27 (12) | 113 (7) | 140 (8) | |
| Smoking status (n = 1795) | .86 | |||
| Never | 180 (80) | 1269 (81) | 1449 (81) | |
| Ever | 45 (20) | 301 (19) | 346 (19) | |
| Blood pressure (systolic/diastolic), mm Hg (n = 1767) | 102/69 (93/60–110/75) | 109/70 (100/63–119/78) | 108/70 (99/63–118/77) | SBP <.001; DBP .006 |
| BMI, kg/m2 (n = 1797) | 18.0 (16.2–19.8) | 19.3 (17.4–21.6) | 19.2 (17.2–21.4) | <.001 |
| MUAC, cm (n = 1804) | 22.6 (20.2–24.7) | 24.0 (22.0–26.3) | 24.0 (21.8–26.0) | <.001 |
| Grip strength, kg (n = 1772) | 20.0 (15.3–25.6) | 25.1 (19.9–31.4) | 24.5 (19.3–31.0) | <.001 |
| Fat mass, kg (n = 1743) | 4.6 (1.8–8.9) | 6.7 (3.8–12.5) | 6.5 (3.6–12.2) | <.001 |
| Fat-free mass, kg (n = 1743) | 40.9 (37.2–47.3) | 43.9 (39.4–49.7) | 43.5 (39.0–49.4) | <.001 |
| HIV VL, copies/mL (n = 1790) | 332260 (132020–1000000) | 240000 (93000–554010) | 249765 (95630–606310) | |
| Log10 HIV VL (n = 1790) | 5.5 (5.1–6.0) | 5.4 (5.0–5.7) | 5.4 (5.0–5.8) | <.001 |
| CD4 count, cells/µL | 25 (10–51) | 38 (17–64) | 37 (16–63) | <.001 |
| Hemoglobin, g/dL (n = 1802) | 10.0 (8.4–11.6) | 11.4 (9.7–12.8) | 11.2 (9.6–12.7) | <.001 |
| WBC count, 109/L (n = 1802) | 3.9 (2.9–5.4) | 3.5 (2.7–4.6) | 3.5 (2.7–4.7) | <.001 |
| Platelets, 109/L (n = 1801) | 260 (189–341) | 251 (182–343) | 252 (183–343) | .88 |
| Neutrophils, 109/L (n = 1785) | 1.99 (1.38–3.07) | 1.69 (1.15–2.50) | 1.72 (1.17–2.58) | <.001 |
| Albumin, g/L (n = 1755) | 30 (26–35) | 35 (31–40) | 35 (30–40) | <.001 |
| eGFRb, mL/min (n = 1793) | 85.3 (60.4–111.3) | 98.8 (79.3–122.4) | 97.3 (77.3–121.1) | <.001 |
| Hospitalized at randomization | 11 (5) | 11 (1) | 22 (1) | <.001 |
| Previous healthcare contactc | 23 (10) | 140 (9) | 163 (9) | .50 |
| Patient-reported symptoms at enrollment | ||||
| Fever | 70 (31) | 170 (11) | 240 (13) | <.001 |
| Weight loss | 147 (65) | 759 (48) | 906 (50) | <.001 |
| Difficulty walking | 86 (38) | 148 (9) | 234 (13) | <.001 |
| Rash | 34 (15) | 291 (18) | 325 (18) | .22 |
| Numbness | 60 (27) | 293 (19) | 353 (20) | .004 |
| Abdominal ache | 39 (17) | 157 (10) | 196 (11) | .001 |
| Sore mouth | 34 (15) | 148 (9) | 182 (10) | .004 |
| Vomiting | 39 (17) | 75 (5) | 114 (6) | <.001 |
| Physician-assessed illnesses | ||||
| Current wasting/severe weight loss (WHO stage 3/4) | 64 (28) | 263 (17) | 327 (18) | <.001 |
| Current TB (all) (WHO stage 3/4) | 48 (21) | 223 (14) | 271 (15) | .003 |
| Current Candida infection (WHO stage 3/4) | 17 (8) | 82 (5) | 99 (5) | .10 |
| EQ-5D | ||||
| Mobility (n = 1791) | <.001 | |||
| No problems walking | 102 (46) | 1297 (83) | 1399 (78) | |
| Some problems walking | 103 (47) | 261 (17) | 364 (20) | |
| Confined to bed | 16 (7) | 12 (1) | 28 (2) | |
| Self-care (n = 1791) | <.001 | |||
| No problems washing/dressing | 110 (50) | 1318 (84) | 1428 (80) | |
| Some problems washing/dressing | 74 (33) | 212 (14) | 286 (16) | |
| Unable to wash/dress myself | 37 (17) | 40 (3) | 77 (4) | |
| Usual activities (n = 1791) | <.001 | |||
| No problems with usual activities | 91 (41) | 1160 (74) | 1251 (70) | |
| Some problems with usual activities | 80 (36) | 319 (20) | 399 (22) | |
| Unable to do usual activities | 50 (23) | 91 (6) | 141 (8) | |
| Pain/discomfort (n = 1791) | <.001 | |||
| No pain/discomfort | 93 (42) | 1009 (64) | 1102 (62) | |
| Moderate pain/discomfort | 116 (52) | 517 (33) | 633 (35) | |
| Extreme pain/discomfort | 12 (5) | 44 (2) | 56 (3) | |
| Anxiety (n = 1791) | <.001 | |||
| Not anxious/depressed | 121 (55) | 1191 (76) | 1312 (73) | |
| Moderately anxious/depressed | 89 (40) | 348 (22) | 437 (24) | |
| Extremely anxious/depressed | 11 (5) | 31 (2) | 42 (2) | |
| WHO stage | <.001 | |||
| 1 | 22 (10) | 278 (18) | 300 (17) | |
| 2 | 44 (19) | 510 (32) | 554 (31) | |
| 3 | 105 (47) | 586 (37) | 691 (38) | |
| 4 | 54 (24) | 206 (13) | 260 (14) | |
| Randomized to enhanced prophylaxis | 98 (44) | 808 (51) | 906 (50) | .03 |
| Randomized to adjunctive raltegravir | 110 (49) | 792 (50) | 902 (50) | .77 |
| Randomized to adjunctive ready-to-use food | 111 (49) | 786 (50) | 897 (50) | .94 |
Data are presented as No. (%) or median (interquartile range).
Abbreviations: BMI, body mass index; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; EQ-5D, EuroQol 5 Dimensions (score); HIV, human immunodeficiency virus; MUAC, mid-upper arm circumference; SBP, systolic blood pressure; TB, tuberculosis; VL, viral load; WBC, white blood cell; WHO, World Health Organization.
aFrom Cox model.
bEstimated using Cockcroft-Gault formula.
cChronic health conditions or prescribed medications >14 days prior to screening visit.