Table 3.
Poisson regression models comparing number of events, in study monitoring efficacy of ART, Tororo and Busia Districts, Uganda, 2003-2007. Intention to treat analysis unless otherwise specified
| Episodes/participants | Person-years of follow-up | Rate per 100 person years | Incidence ratio (95% CI); P value | |||||
|---|---|---|---|---|---|---|---|---|
| Unadjusted | Adjusted* | |||||||
| Compared with viral load arm | Compared with CD4 arm | Compared with viral load arm | Compared with CD4 arm | |||||
| New CDC category C illnesses | ||||||||
| Viral load arm | 33/368 | 1002.6 | 3.3 | — | — | — | — | |
| CD4 arm | 46/371 | 1008.7 | 4.6 | 1.39 (0.89 to 2.17); 0.153 | — | 1.62 (0.83 to 3.15); 0.158 | — | |
| Clinical arm | 67/377 | 1003.4 | 6.7 | 2.03 (1.34 to 3.08); 0.001 | 1.46 (1.01 to 2.13); 0.046 | 3.37 (1.84 to 6.14); <0.0001 | 2.08 (1.25 to 3.46); 0.005 | |
| New CDC category C illnesses (per protocol analysis) | ||||||||
| Viral load arm | 15/349 | 891.9 | 1.7 | — | — | — | — | |
| CD4 arm | 23/346 | 897.8 | 2.6 | 1.52 (0.79 to 2.92); 0.205 | — | 1.34 (0.84 to 2.15); 0.222 | — | |
| Clinical arm | 46/352 | 890.1 | 5.2 | 3.07 (1.72 to 5.50); 0.0002 | 2.02 (1.22 to 3.33); 0.006 | 2.47 (1.60 to 3.82); <0.0001 | 1.84 (1.24 to 2.73); 0.002 | |
| Tuberculosis | ||||||||
| Viral load arm | 29/368 | 1002.6 | 2.9 | — | — | — | — | |
| CD4 arm | 27/371 | 1008.7 | 2.7 | 0.93 (0.55 to 1.56); 0.772 | — | 0.92 (0.53 to 1.61); 0.783 | — | |
| Clinical arm | 37/377 | 1003.4 | 3.7 | 1.27 (0.78 to 2.07); 0.328 | 1.38 (0.84 to 2.26); 0.206 | 1.56 (0.94 to 2.60); 0.084 | 1.69 (1.01 to 2.85); 0.047 | |
| Extrapulmonary tuberculosis | ||||||||
| Viral load arm | 3/368 | 1002.6 | 0.3 | — | — | — | — | |
| CD4 arm | 7/371 | 1008.7 | 0.7 | 2.32 (0.60 to 8.97); 0.223 | — | 3.02 (0.61 to 15.01); 0.177 | — | |
| Clinical arm | 14/377 | 1003.4 | 1.4 | 4.66 (1.34 to 16.23); 0.016 | 2.01 (0.81 to 4.98); 0.131 | 7.27 (1.64 to 32.30); 0.009 | 2.41 (0.92 to 6.33); 0.074 | |
| Cryptococcal infection | ||||||||
| Viral load arm | 11/368 | 1002.6 | 1.1 | — | — | — | — | |
| CD4 arm | 11/371 | 1008.7 | 1.1 | 0.99 (0.43 to 2.29); 0.989 | — | 0.74 (0.30 to 1.84); 0.516 | — | |
| Clinical arm | 22/377 | 1003.4 | 2.2 | 2.00 (0.97 to 4.12); 0.061 | 2.01 (0.97 to 4.15); 0.059 | 2.21 (1.06 to 4.59); 0.034 | 2.99 (1.32 to 6.77); 0.009 | |
| Kaposi’s sarcoma | ||||||||
| Viral load arm | 4/368 | 1002.6 | 0.4 | — | — | — | — | |
| CD4 arm | 7/371 | 1008.7 | 0.7 | 1.74 (0.51 to 5.94); 0.377 | — | 1.50 (0.42 to 5.35); 0.528 | — | |
| Clinical arm | 11/377 | 1003.4 | 1.1 | 2.75 (0.87 to 8.63); 0.083 | 1.58 (0.61 to 4.08); 0.344 | 2.75 (0.87 to 8.70); 0.084 | 1.83 (0.67 to 5.01); 0.239 | |
| Pneumocystis jirovecii pneumonia | ||||||||
| Viral load arm | 2/368 | 1002.6 | 0.2 | — | — | — | — | |
| CD4 arm | 1/371 | 1008.7 | 0.1 | 0.50 (0.05 to 5.48); 0.568 | — | 0.58 (0.05 to 6.46); 0.659 | — | |
| Clinical arm | 11/377 | 1003.4 | 1.1 | 5.50 (1.22 to 24.79); 0.027 | 11.06 (1.43 to 85.7); 0.021 | 9.57 (1.96 to 46.71); 0.005 | 16.5 (2.04 to 132.6); 0.009 | |
*Adjusted for age, sex, baseline CD4 cell count, baseline viral load, and BMI.