Table 3. Characteristics of HIV-associated cryptococcal meningitis trials within different time periods and overall.
Where data were not available, the number of trials with available data is presented as a denominator.
| PRE-2000 | 2000–2009 | 2010 ONWARDS | OVERALL N(%) | |||
|---|---|---|---|---|---|---|
| TRIAL DESIGN | ||||||
| Number of trials | 14 | 14 | 11 | 39 | ||
| Focus of trial | Induction | 10 (71%) | 10 (71%) | 9 (82%) | 29 (74%) | |
| Maintenance | 3 (21%) | 2 (14%) | 0 | 5 (13%) | ||
| ART timing | 0 | 1 (7%) | 2 (18%) | 3 (8%) | ||
| Other | 1 (7%) | 1 (7%) | 0 | 2 (5%) | ||
| Primary outcome | Mortality | 0 | 1 (7%) | 6 (55%) | 7 (18%) | |
| Microbiological | 4 (29%) | 7 (50%) | 5 (45%) | 16 (41%) | ||
| Clinical | 3 (21%) | 6 (43%) | 0 | 9 (23%) | ||
| Combined | 7 (50%) | 0 | 0 | 7 (18%) | ||
| Inclusion | HIV infected only | 14 (100%) | 13 (93%) | 11 (100%) | 38 (97%) | |
| First episode only | 4/7 (57%) | 9/10 (90%) | 7/7 (100%) | 20/24 (83%) | ||
| ART naïve only | 0/5 | 5/6 (83%) | 4/9 (44%) | 9/20 (45%) | ||
| SCREENING AND RANDOMISATION | ||||||
| Number of studies with data | 1 | 7 | 10 | 18 | ||
| Number screened | 42 | 965 | 4,004 | 5,011 | ||
| Number screened out | 16 | 589 | 1,643 | 2,248 | ||
| % screen failures | 38% | 61% | 41% | 45% | ||
| Screen failures | Declined | 6 (14%) | 66 (7%) | 292 (7%) | 364 (7%) | |
| Pregnant | 0 | 2 (0.2%) | 10 (0.2%) | 12 (0.2%) | ||
| Lactating | 0 | 0 | 5 (0.1%) | 5 (0.1%) | ||
| Number randomised | 1,814 | 797 | 2,455 | 5,066 | ||
| Withdrawal | Number of studies with data | 13 | 14 | 11 | 38 | |
| Number randomised | 1,759 | 797 | 2,455 | 5,011 | ||
| Late exclusion | 132 (8%) | 26 (3%) | 50 (2%) | 208 (4%) | ||
| Withdrawal of consent | 24 (1%) | 3 (0.4%) | 8 (0.3%) | 35 (1%) | ||
| Loss to follow-up | 58 (3%) | 48 (6%) | 16 (0.7%) | 122 (2%) | ||
| PARTICIPANTS | P value | |||||
| Gender | Number of studies with data | 13 | 14 | 11 | 38 | |
| Number male | 1,454 | 480 | 1,494 | 3,427 | ||
| Number female | 183 | 285 | 901 | 1,369 | ||
| % female | 11% | 37% | 38% | 29% | p < 0.0001* | |
| ART status | Number of studies with data | 7 | 9 | 9 | 25 | |
| Number ART naïve | 906 | 594 | 1,196 | 2,696 | ||
| Number ART experienced | 288 | 11 | 889 | 1,188 | ||
| % ART experienced | 24% | 2% | 43% | 31% | p < 0.0001* | |
| Episode | Number of studies with data | 6 | 9 | 7 | 22 | |
| Number first episode | 997 | 557 | 1,822 | 3,376 | ||
| Number relapse | 28 | 0 | 0 | 28 | ||
| % relapse | 3% | 0% | 0% | 1% | p < 0.0001* | |
| Baseline GCS | Number of studies with data | 8 | 9 | 9 | 26 | |
| Number GCS 15 | 765 | 410 | 1,654 | 2,829 | ||
| Number GCS <15 | 131 | 58 | 697 | 886 | ||
| % number GCS <15 | 15% | 12% | 30% | 24% | p < 0.0001* | |
ART, antiretroviral therapy; GCS, Glasgow Coma Scale.
*Statistically significant.