Table 3.
Secondary outcomes at six months post-randomization by randomization arm
| All subjects (n=128) Median (IQR)/n (%) |
Urgent arm (n=62) Median (IQR)/n (%) |
Post-stabilization arm (n=66) Median (IQR)/n (%) |
p-value | |
|---|---|---|---|---|
| Viral, immunology, and hematology markers | ||||
|
| ||||
| Log10 HIV RNAa | 2·1 (1·3, 3·5) | 2·2 (1·3, 3·5) | 2·1 (1·3, 3·7) | 0·88 |
| HIV RNA <40 copies/mL | 45/121 (37) | 23/59 (39) | 2362 (35) | 0·69 |
| HIV RNA <400 copies/mL | 77/121 (64) | 35/59 (59) | 42/62 (68) | 0·34 |
| HIV RNA <1000 copies/mL | 86/121 (71) | 42/59 (71) | 44/62 (71) | 0·98 |
| Change in log10 HIV RNAb | −3·3 (−4·0, −1·7) | −3·5 (−4·1, −1·7) | −3·2 (−4·0, −1·7) | 0·71 |
| CD4 count (cells/μL)c | 1183 (670, 1791) | 1123 (670, 1692) | 1274 (733 to 1911) | 0.31 |
| Change in CD4 count from baselinec | 433 (85, 734) | 426·5 (146, 682) | 491 (60.5 to 860.5) | 0.46 |
| CD4%c | 21·9 (15·5, 27·0) | 22·4 (16·3, 26·0) | 20·9 (14·0, 27·8) | 0.73 |
| Change in CD4% from baselinec | 7·1 (1·3, 11·6) | 7·2 (3·0, 11·6) | 6·2 (0·0, 11·7) | 0.26 |
| Hemoglobinc | 11·0 (10·1, 12·0) | 11·3 (10·2, 11·9) | 10·9 (9·8, 12·0) | 0.37 |
| Change in hemoglobin from baselinec | 2·2 (1·0, 3·6) | 2·6 (1·3, 3·9) | 1·7 (0·5, 3·5) | 0·04 |
| Total lymphocyte count (TLC) (cells/mm3)d | 5520 (3620 to 8250) | 5240 (3200 to 7880) | 5915 (3970 to 9560) | 0.21 |
| Change in TLC from baselinee | 310 (−1340 to 2070) | −375 (−2350 to 1040) | 820 (−840 to 2810) | 0.003 |
|
| ||||
| Growth | ||||
|
| ||||
| WAZ scoref | −1·4 (−2·1, −0·7) | −1·3 (−2·0, −0·6) | −1·4 (−2·5, −0·9) | 0·29 |
| WAZ <-2 | 37/120 (31) | 16/59 (27) | 21/61 (34) | 0·39 |
| Change in WAZ from baselinef | 0·8 (0·1, 2·0) | 0·9 (0·1, 2·1) | 0·8 (0·1, 1·9) | 0·68 |
| HAZ scorec | −2·1 (−3·1, −1·0) | −1·8 (−3·0, −0·7) | −2·4 (−3·3, −1·1) | 0·13 |
| HAZ <-2 | 69/126 (55) | 29/62 (47) | 40/64 (63) | 0·08 |
| Change in HAZ from baselinec | 0·3 (−0·1, 0·7) | 0·4 (−0·1, 0·9) | 0·2 (−0·1, 0·6) | 0·15 |
| WHZ scoreg | −0·4 (−1·3, 0·6) | −0·4 (−1·0, 0·6) | −0·4 (−1·4, 0·7) | 0·79 |
| WHZ<-2 | 12/87 (14) | 4/39 (10) | 8/48 (17) | 0·54 |
| Change in WHZ from baselineg | 1·1 (−0·1, 2·9) | 1·3 (0·0, 3·1) | 1·0 (−0·1, 2·3) | 0·31 |
|
| ||||
| Clinical and treatment outcomes | ||||
|
| ||||
| WHO stage I or II | 76/128 (59) | 38/62 (61) | 38/66 (58) | 0·67 |
| Missed ART in last three days | 4/128 (3) | 4/62 (6) | 0/66 (0) | 0·05* |
a
n=121;
b
n=115;
c
n=126′
d
n=125;
e
n=124;
f
n=120;
g
n=87′
*
Fishers exact test