Table 3. Clinical events triggering switch after 44 weeks on ART in patients monitored without CD4 cell counts (CDM).
| No CD4 monitoring (CDM) | |||||
| Clinical events triggering switch after 44 weeks on ART | N[accepted by ERC] (%) | Median (IQR) CD4 | n≥250 cells/mm3(%) | n<50 cells/mm3(%) | n died within 1 year of switch(%) |
| WHO 4 | 207 (100%) | 47 (15–165) | 33(16%) | 105(51%) | 39(19%) |
| Oesophageal candidiasis | 76 [70] (37%) | 30 (8–68) | 3(4%) | 47(62%) | 8(11%) |
| Cryptococcal meningitis | 33 [28] (16%) | 70 (16–270) | 11(33%) | 15(45%) | 11(33%) |
| Extra–pulmonary TB | 26 [22] (13%) | 78 (23–188) | 3 (12%) | 9 (35%) | 5 (19%) |
| HIV wasting | 23 [17] (11%) | 58 (12–149) | 4 (17%) | 9 (39%) | 7 (30%) |
| Herpes simplex, mucotaneous | 14 [10] (7%) | 30 (16–242) | 3 (21%) | 8 (57%) | 2 (14%) |
| Cryptosporidiosis | 13 [12] (6%) | 30 (18–203) | 3 (23%) | 8 (62%) | 1 (8%) |
| PCP | 7 [3] (3%) | 17 (5–72) | 0 (0%) | 5 (71%) | 1 (14%) |
| Lymphoma | 4 [3] (2%) | 373 (178–460) | 3 (75%) | 1 (25%) | 3 (75%) |
| KS | 4 [3] (2%) | 149 (66–244) | 1 (25%) | 1 (25%) | 1 (25%) |
| Toxoplasmosis | 2 [2] (1%) | 28 (5,52) | 0 (0%) | 1 (50%) | 0 (0%) |
| CMV | 2 [2] (1%) | 410 (244,575) | 1 (50%) | 0 (0%) | 0 (0%) |
| Multiple WHO 3 | 30 (100%) | 19 (9–79) | 3 (10%) | 18 (60%) | 1 (3%) |
| Weight loss, oral candida | 12 (40%) | 12 (9–57) | 1 (8%) | 8 (67%) | 1 (8%) |
| Weight loss, SBI | 6 (20%) | 54 (10–71) | 0 (0%) | 3 (50%) | 0 (0%) |
| Oral candida, SBI | 4 (13%) | 26 (14–166) | 1 (25%) | 3 (75%) | 0 (0%) |
| Oral candida, pulmonary TB | 2 (7%) | 8 (3,13) | 0 (0%) | 2 (100%) | 0 (0%) |
| Multiple SBI | 2 (7%) | 116 (79,153) | 0 (0%) | 0 (0%) | 0 (0%) |
| Single WHO3 | 77 (100%) | 102 (23–364) | 28 (36%) | 28 (36%) | 4 (5%) |
| Weight loss | 41 (53%) | 224 (37–409) | 18 (44%) | 11 (27%) | 1 (2%) |
| Oral candida | 20 (26%) | 31 (12–138) | 4 (20%) | 12 (60%) | 0 (0%) |
| SBI | 7 (9%) | 55 (19–303) | 3 (43%) | 3 (43%) | 1 (14%) |
| Pulmonary TB | 5 (6%) | 71 (27–98) | 1 (20%) | 2 (40%) | 0 (0%) |
| Diarrhoea | 2 (3%) | 490 (327,652) | 2 (100%) | 0 (0%) | 1 (50%) |
Note: SBI = severe bacterial infection; OHL = oral hairy leukoplakia; ERC = Endpoint Review Committee (blinded to randomised group). Data not shown for events with only 1 associated switch: visceral herpes simplex, HIV encephalopathy, recurrent pneumonia, weight loss+persistent fever, weight loss+oral candida+SBI, oral candida+OHL, pulmonary TB+SBI, HIV nephropathy, OHL). Additional new/recurrent WHO events which occurred during the first year on ART are included in the main trial report[4], but not here as switch to second-line for first-line failure only occurred after 1 year.