Table 2. Primary and Secondary Time-to-Event End Points.
| End Point | Co-trimoxazole Prophylaxis Continued (N = 376) | Co-trimoxazole Prophylaxis Stopped (N = 382) | Hazard Ratio (95% CI)* | P Value† |
|---|---|---|---|---|
| Primary efficacy end point: hospitalization or death — no. (%) | 48 (13) | 72 (19) | 1.64 (1.14–2.37) | 0.007 |
| According to CD4 T-cell percentage at randomization — no./total no. (%) | 0.08 | |||
| ≥30% | 23/237 (10) | 46/238 (19) | 2.15 (1.30–3.54) | |
| 15–29% | 19/126 (15) | 17/119(14) | 0.96 (0.50–1.85) | |
| 0–14% | 6/13 (46) | 9/25 (36) | 0.81 (0.29–2.27) | |
| According to ART monitoring strategy — no./ total no. (%) | 0.69 | |||
| CD4 T-cell monitoring | 21/185 (11) | 29/189 (15) | 1.44 (0.82–2.52) | |
| No CD4 T-cell monitoring | 27/191 (14) | 43/193 (22) | 1.67 (1.03–2.71) | |
| According to age at randomization — no./ total no. (%) | 0.93 | |||
| 3–6 yr | 24/176 (14) | 33/158 (21) | 1.69 (1.00–2.86) | |
| 7–12 yr | 18/162 (11) | 29/175 (17) | 1.53 (0.85–2.75) | |
| ≥13 yr | 6/38 (16) | 10/49 (20) | 1.38 (0.50–3.79) | |
| According to country — no./total no. (%) | 0.91 | |||
| Uganda | 40/283 (14) | 60/286 (21) | 1.59 (1.06–2.37) | |
| Zimbabwe | 8/93 (9) | 12/96 (12) | 1.51 (0.62–3.68) | |
| Hospitalization or death due to malaria — no. (%)‡ | 18 (5) | 36 (9) | 2.15 (1.22–3.78) | 0.007 |
| Hospitalization or death due to infection other than malaria — no. (%)J | 21 (6) | 39 (10) | 1.95 (1.15–3.32) | 0.01 |
| Malaria — no. (%) | 39 (10) | 77 (20) | 2.21 (1.50–3.25) | <0.001 |
| Primary safety end point: grade 3 or 4 adverse event — no. (%) | 55 (15) | 64 (17) | 1.20 (0.83–1.72) | 0.33 |
| Grade 4 adverse event — no. (%) | 11 (3) | 22 (6) | 2.04 (0.99–4.22) | 0.05 |
Hazard ratios were stratified according to center, monitoring group, and treatment group (i.e., the randomization stratification factors; unstratified hazard ratios were similar), except for subgroup analyses in which numbers within individual subgroups were too small for further stratification.
For subgroup analyses, the P values listed are for the test of heterogeneity. For other analyses, P values are for the log-rank test of stopping versus continuing prophylaxis.
Post hoc analyses included the two main components of the composite end point (hospitalization or death due to malaria, and hospitalization or death due to infection other than malaria). The numbers of participants do not add up to the total for the primary end point because a small number of participants were hospitalized for both malaria and infection other than malaria, and some were hospitalized only for a noninfectious disorder (Table S3 in the Supplementary Appendix).