Table 1.
Baseline characteristics of the patients in the SAPIT trial*
| Variable | Early integrated-therapy group (N =214) |
Late integrated-therapy group (N = 215) |
Total (N = 429) |
p-value |
|---|---|---|---|---|
| Number (%) | Number (%) | Number (%) | ||
| Age –year | 0.75 | |||
| Mean Range |
34.3 ± 8.0 19 – 63 |
34.5 ± 8.7 21 – 72 |
34.4 ± 8.4 19–72 |
|
| Male sex | 97 (45.3) | 112 (52.1) | 209 (48.7) | 0.18 |
| Educational levelγ | 0.23 | |||
| Primary school or less | 43 (20.2) | 49 (22.9) | 92 (21.5) | |
| Some secondary school | 97 (45.5) | 108 (50.5) | 205 (48.0) | |
| Secondary complete | 73 (34.3) | 57 (26.6) | 130 (30.4) | |
| Employed | 135 (63.1) | 117 (54.4) | 252 (58.7) | 0.08 |
| History of tuberculosis | 80 (37.4) | 68 (31.6) | 148 (34.5) | 0.22 |
| Karnofsky score | 0.84 | |||
| 100 or 90 | 123 (57.5) | 128 (59.5) | 251 (58.5) | |
| 80 or 70 | 86 (40.2) | 81 (37.7) | 167 (38.9) | |
| < 70 | 5 (2.3) | 6 (2.8) | 11 (2.6) | |
| WHO stage 4 at baseline§ | 14 (6.5) | 11 (5.1) | 25 (5.8) | 0.54 |
| Presence of extra-pulmonary tuberculosis | 10 (4.7) | 9 (4.2) | 19(4.4) | 0.82 |
| Presence of resistance to tuberculosis drugs: n/N (%) | ||||
| Isoniazid Rifampin Ethambutol |
13/102 (12.7) 8/102 (7.8) 1/101 (1.0) |
5/101 (5.0) 4/101 (4.0) 0/100 (0.0) |
18/203 (8.5) 12/203 (5.7) 1/201 (0.5) |
0.08 0.37 1.00 |
| Presence of multi-drug resistant tuberculosis | 6/106 (5.7) | 3/101 (3.0) | 9/207 (4.4) | 0.50 |
| Median (interquartile range) | Median (interquartile range) | |||
| CD4+ count,-cells/mm3† | 154.5 (75 to 261) |
149 (77 to 244) |
150.0 (77 to 254) |
0.93 |
| log viral load copies/ml ‡ | 5.13 (4.5 to 5.6) |
5.23 (4.5 to 5.6) |
5.17 (4.5 to 5.6) |
0.53 |
| Number of days on tuberculosis therapy at randomization | 9 (7–13) |
9 (7–14) |
9 (7–14) |
0.49 |
γ
Educational level was not available for 1 patient in each of the groups
*
Plus–minus values are means ±Standard Deviation.
†
Patients underwent randomization on the basis of the CD4+ count at screening (criterion for study enrollment, <500 cells per cubic millimeter). However, for 16 patients, the CD4+ count at enrollment was 500 cells per cubic millimeter or higher.
‡
Baseline viral load was not available for 16 patients in each of the groups
§
The remainder of patients had stage 3 infection, according to criteria of the World Health Organization (WHO).