Table 2.
Primary outcomes during six months follow-up by randomization arm
| All subjects (N=181) Median (IQR)/n (%) |
Urgent arm (n=90) Median (IQR)/n (%) |
Post-stabilization arm (n=91) Median (IQR)/n (%) |
Hazard ratio 95% CI |
p-value | |
|---|---|---|---|---|---|
| Days to ART initiation | 2 (1, 8) | 1 (1, 1) | 8 (7, 11) | ||
| ART regimen | 0·38a | ||||
| LPV/r-based | 68/168 (40) | 38/87 (44) | 30/81 (37) | ||
| NNRTI-based | 100/168 (60) | 49/87 (56) | 51/81 (63) | ||
| No endpoint information | 14/181 (8) | 7/90 (8) | 7/91 (8) | 0·98a | |
|
| |||||
| Primary endpoints at six months | |||||
|
| |||||
| Mortality | |||||
| Deaths | 39/181 (22) | 21/90 (23) | 18/91 (20) | 1·26 (0·67–2·37) | 0·47b |
| Overall mortality rate per 100 py | 61 | 70 | 54 | 1·30 (0·69–2·44) | 0·41c |
| Deaths 0 to one month | 33/181 (18) | 20/90 (22) | 13/91 (14) | 1·66 (0·82–3·33) | 0·16b |
| Mortality rate (0 to one month) per 100 py | 265 | 336 | 199 | 1·69 (0·84–3·39) | 0·14c |
| Deaths one to three months | 6/140 (4) | 1/66 (2) | 5/74 (7) | 0·22 (0·03–1·89) | 0·17b |
| Mortality rate (one to three months) per 100 py | 27 | 9 | 44 | 0·22 (0·03–1·86) | 0·16c |
| Death three to six months | 0/130 (0) | 0/64 (0) | 0/66 (0) | - | - |
| Mortality rate (three to six months) per 100 py | 0 | 0 | 0 | - | - |
| IRIS | |||||
| Overall IRIS cases (any IRIS)e | 22/181 (12) | 10/90 (11) | 12/91 (13) | 0·96 (0·41–2·23) | 0·92b |
| Age <=one year | 5/48 (10) | 1/23 (4) | 4/25 (16) | 0.33 (0.04–2.92) | 0.32 |
| Age one to five years | 13/89 (15) | 8/43 (19) | 5/46 (11) | 2.01 (0.65–6.21) | 0.22 |
| Age >five years | 4/44 (9) | 1/24 (4) | 3/20 (15) | 0.27 (0.03–2.63) | 0.26 |
| Confirmed IRIS cases | 3/22 (14) | 1/10 (10) | 2/12 (17) | ||
| Likely IRIS cases | 7/22 (32) | 3/10 (30) | 4/12 (33) | ||
| Possible IRIS cases | 12/22 (55) | 6/10 (60) | 6/12 (50) | ||
| Overall IRIS incidence (any IRIS) per 100 pyd | 37 | 36 | 39 | 0·91 (0·39–2·10) | 0·82c |
| IRIS cases (confirmed or likely) | 10/181 (6) | 4/90 (4) | 6/91 (7) | 0·81 (0·22–2·89) | 0·74b |
| IRIS incidence per 100 pye | 17 | 14 | 19 | 0·74 (0·21–2·62) | 0·64c |
| Toxicity | |||||
| Clinical drug toxicity cases | 14/152 (9) | 9/75 (12) | 5/77 (6) | 2·00 (0·67–5·98) | 0·21b |
| Clinical drug toxicity incidence per 100 py | 24 | 32 | 16 | 2·03 (0·68–6·06) | 0·20c |
| Laboratory drug toxicity cases | 24/139 (17) | 14/69 (20) | 10/70 (14) | 1·57 (0·70–3·53) | 0·28b |
| Laboratory drug toxicity incidence per 100 py | 42 | 53 | 32 | 1·62 (0·72–3·64) | 0·25c |
|
| |||||
| Safety outcomes at six months | |||||
|
| |||||
| Any adverse events grade three or four | 74/181 (41) | 34/90 (38) | 40/91 (44) | 0·40a | |
| Any ART change in regimen | 11/181 (7) | 5/90 (7) | 6/91 (8) | 0.79a | |
a
Chi-square test;
b
Hazard ratio from Cox regression;
c
Incident rate ratio from Poisson regression;
d
Confirmed, possible and likely versus no IRIS;
e
Confirmed and likely versus possible or no IRIS;