Table 1. Characteristics at enrolment.
| Factor | Standard ART (N = 903) |
Raltegravir-intensified (N = 902) |
All (N = 1,805) |
|---|---|---|---|
| Male | 482 (53.4%) | 479 (53.1%) | 961 (53.2%) |
| Age at last birthday (years) | 36 (29–42) [5–77] | 35 (29–42) [6–72] | 36 (29–42) [5–77] |
| 5–17 years | 33 (3.7%) | 39 (4.3%) | 72 (4.0%) |
| HIV VL (c/mL) (N = 1,804) | 250,000 (95,450–631,560) |
246,700 (94,000–578,080) |
249,770 (95,280–606,360) |
| ≥100,000 c/mL | 667/902 (73.9%) | 667/902 (73.9%) | 1,334/1,804 (73.9%) |
| <1,000 c/mL** | 7/902 (0.8%) | 7/902 (0.8%) | 14/1,804 (0.8%) |
| CD4 count* (cells/mm3) | 36 (16–61) | 38 (16–64) | 37 (16–63) |
| 0–24 cells/mm3 | 335 (37.1%) | 321 (35.6%) | 656 (36.3%) |
| 25–49 cells/mm3 | 256 (28.3%) | 253 (28.0%) | 509 (28.2%) |
| Weight* (kg) (N = 1,800) | 52.9 (46.7–59.8) | 52.3 (45.8–59.0) | 52.5 (46.3–59.3) |
| BMI (kg/m2) (N = 1,797) | 19.3 (17.5–21.6) | 19.0 (17.1–21.2) | 19.2 (17.2–21.4) |
| <18 kg/m2 | 302/900 (33.6%) | 323/897 (36.0%) | 625/1,797 (34.8%) |
| WHO stage | |||
| 1 | 145 (16.1%) | 155 (17.2%) | 300 (16.6%) |
| 2 | 290 (32.1%) | 264 (29.3%) | 554 (30.7%) |
| 3 | 341 (37.8%) | 350 (38.8%) | 691 (38.3%) |
| 4 | 127 (14.1%) | 133 (14.7%) | 260 (14.4%) |
| Current tuberculosis disease | 137 (15.2%) | 134 (14.9%) | 271 (15.0%) |
| Haemoglobin (g/L) (N = 1,800) | 112 (96–127) | 111 (95–127) | 112 (96–127) |
| ≤80 g/L | 86 (9.6%) | 90 (10.0%) | 176 (9.8%) |
| NRTIs | |||
| Tenofovir/emtricitabine | 719 (79.6%) | 703 (77.9%) | 1,422 (78.8%) |
| Zidovudine/lamivudine | 154 (17.1%) | 169 (18.7%) | 323 (17.9%) |
| Abacavir/lamivudine | 30 (3.3%) | 30† (3.3%) | 60 (3.3%) |
| NNRTI | |||
| Efavirenz | 816‡ (90.4%) | 803 (89.0%) | 1,619 (89.7%) |
| Nevirapine | 87 (9.6%) | 99 (11.0%) | 186 (10.3%) |
| Randomised to receive enhanced anti-infection prophylaxis | 451 (49.9%) | 455 (50.4%) | 906 (50.2%) |
| Randomised to receive RUSF | 449 (49.7%) | 448 (49.7%) | 897 (49.7%) |
*Mean of screening and enrolment values. Eligibility required screening CD4 to be <100 cells/mm3, so baseline can be above 100, depending on the CD4 at enrolment.
**Potentially indicating undisclosed prior ART: median CD4 was 76 cells/mm3 in these participants.
†One child was mistakenly initiated on Aluvia (lopinavir/ritonavir) rather than abacavir/lamivudine (plus efavirenz and raltegravir); substituted with abacavir/lamivudine after 4 weeks.
‡One adult took tenofovir/emtricitabine alone for 4 days in error before adding efavirenz on day 4.
Note: Showing n (%) or median (IQR) [range].
Abbreviations: CD4, cluster of differentiation 4; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; RUSF, ready-to-use supplementary food; VL, viral load.