Table 3.
Safety data.
| All patients |
Control (AmB/5FC) |
AmB/5FC IFNγ 2 doses |
AmB/5FC P IFNγ 6 doses |
P value * |
|
|---|---|---|---|---|---|
| n | 90 | 31 | 27 $ | 30 | |
| Deaths (due to Cryptococcosis) |
16 | 6 | 6 | 4 | 0.65 |
| Deaths (Other causes) |
11 | 4 (HIV wasting syndrome, nosocomial pneumonia, 2 x sepsis) |
3 (nosocomial pneumonia/HIV encephalopathy, gastroenteritis) |
4 (2 x sepsis, TB, unknown) |
0.98 |
| Grade 4 clinical SAE |
23 | 9 (2 x diarrhoea and vomiting, 2 x seizures, 2 x pneumonia, cryptococcal IRIS, GI bleed, scalp laceration) |
8 (2 x vomiting, 2 x sepsis, persistent raised ICP, otitis externa, MRSA drip site/TB infection, cerebral infarct) |
6 (nevirapine toxicity, angioedema, persistent raised ICP, probable PCP, cryptococcal IRIS, TB) |
0.49 |
| Grade 3 |
Lab
SAEs |
||||
| Anaemia | 14 (16%) |
6 (19%) | 4 (15%) | 4 (13%) | 0.88 |
| Leukopaenia | 5 (6%) | 1 (3%) | 2 (8%) | 2 (7%) | 0.74 |
| Neutropaenia | 4 (5%) | 1 (3%) | 1 (4%) | 2 (7%) | 0.84 |
| Thrombocytopaenia | 4 (5%) | 1 (3%) | 1 (4%) | 2 (7%) | 0.84 |
| ALT | 0 | 0 | 0 | 0 | ---- |
| Creatinine | 18 (21%) |
7 (23%) | 5 (19%) | 6 (20%) | 1.00 |
| Potassium↓ | 2 (2%) | 0 | 1 (4%) | 1 (3%) | 0.54 |
| Magnesium↓ | 22 (25%) |
6 (19%) | 9 (35%) | 7 (23%) | 0.40 |
| Sodium↓ | 5 (6%) | 3 (10%) | 0 | 2 (7%) | 0.37 |
| Grade 4 |
Lab
SAEs |
||||
| Anaemia | 17 (18%) |
4 (13%) | 7 (27%) | 6 (20%) | 0.42 |
| Leukopaenia | 0 | 0 | 0 | 0 | ---- |
| Neutropaenia | 3 (3%) | 1 (3%) | 1 (4%) | 1 (3%) | 1.00 |
| Thrombocytopaenia | 1 (1%) | 1 (3%) | 0 | 0 | 1.00 |
| ALT | 0 | 0 | 0 | 0 | ---- |
| Creatinine* | 0 | 0 | 0 | 0 | ---- |
| Potassium↓ | 1 (1%) | 0 | 0 | 1 (3%) | 0.64 |
| Magnesium↓ | 5 (6%) | 1 (3%) | 2 (8%) | 2 (7%) | 0.74 |
| Sodium↓ | 2 (2%) | 0 | 1 (4%) | 1 (3%) | 0.54 |
| IRIS | |||||
| IRIS** | 9/65 (14%) |
2/23 (9%) | 2/18 (11%) | 5/24 (21%) | 0.55 |
| Time to IRIS (days) | 60 (24- 115) |
64 (12-115) | 24 (19-29) | 110 (60-116) | 0.32 |
*
P-values calculated using the Kruskal-Wallis or χ2 tests as appropriate.
$
One patient in this group absconded on day 2 of treatment, and although known to be alive at 2 and 10 weeks, has no reportable laboratory safety monitoring data, hence denominator is 26 for laboratory SAEs.
**
Expressed as percentage of patients who initiated ART.