Table 2.
Main outcomes of the three early ART randomized controlled trials (HPTN052, Temprano ANRS 12136, START)
| Deferred ART | Early ART | Adjusted hazard ratiof (95 % CI) | |||
|---|---|---|---|---|---|
| N | Rate per 100 PY | N | Rate per 100 PY | ||
| Composite primary outcome | |||||
| HPTN052 | 91 | 4.5 | 71 | 3.5 | 0.73 (0.52–1.03) |
| Temprano | 111 | 4.9 | 64 | 2.8 | 0.56 (0.41–0.76) |
| Baseline CD4 < 500 | 73 | 5.5 | 41 | 3.0 | 0.56 (0.38–0.83) |
| Baseline CD4 ≥ 500 | 38 | 4.1 | 23 | 2.4 | 0.56 (0.33–0.94) |
| START | 96 | 1.4 | 42 | 0.6 | 0.43 (0.30–0.62) |
| Separated outcome | |||||
| Deatha | |||||
| HPTN052 | 15 | NA | 11 | NA | 0.73 (0.34–1.59) |
| Temprano | 26 | 1.9 | 21 | 0.8 | 0.80 (0.45–1.40) |
| START | 21 | 0.3 | 12 | 0.2 | 0.58 (0.28–1.17) |
| AIDSa | |||||
| HPTN052 | 61 | NA | 40 | NA | 0.64 (0.43–0.96) |
| Temprano | 65 | 2.8 | 33 | 1.4 | 0.50 (0.33–0.76) |
| START | 50 | 0.7 | 14 | 0.2 | 0.28 (0.15–0.50) |
| Tuberculosisa,b | |||||
| HPTN052 | 34 | 1.8 | 17 | 0.8 | 0.49 (0.28–0.89) |
| Temprano | 55 | 2.4 | 28 | 1.2 | 0.50 (0.32–0.79) |
| START | 20 | 0.3 | 6 | 0.1 | 0.29 (0.12–0.73) |
| AIDS and non-AIDS malignanciesa,c | |||||
| HPTN052 | 7 | NA | 4 | NA | NA |
| Temprano | 6 | NA | 3 | NA | NA |
| START | 39 | NA | 14 | NA | NA |
| Invasive bacterial diseasesd | |||||
| HPTN052 | 13 | NA | 20 | NA | NA |
| Temprano | 36 | 1.5 | 14 | 0.6 | 0.39 (0.21–0.71) |
| START | 36 | 0.5 | 14 | 0.2 | 0.38 (0.20–0.70) |
| Serious cardiovasculare | |||||
| HPTN052 | 3 | NA | 1 | NA | NA |
| Temprano | 6 | NA | 3 | NA | NA |
| START | 14 | 0.20 | 12 | 0.17 | 0.84 (0.39–1.81) |
N number of participants who had at least one such type of outcome; ART antiretroviral treatment; NA non available; PY person-years
aComponent of the composite primary outcome in the three trials
bTotal number of pulmonary and extra pulmonary TB episodes recorded in the three trials: HPTN052: pulmonary, n = 30 (early: 14; deferred: 16); extra-pulmonary, n = 20 (early: 3; deferred: 17); Temprano ANRS 12136: pulmonary, n = 43 (early: 19; deferred: 24); extra-pulmonary, n = 41 (early: 9; deferred: 33). START: pulmonary, n = 23 (early: 6; deferred: 17); extra-pulmonary, n = 3 (early: 0; deferred: 3)
cCervical carcinoma, Kaposi’s sarcoma, Lymphoma, Hodgkin’s, Lymphoma, non-Hodgkin’s non-AIDS cancers
dInvasive bacterial diseases were a component of the composite primary outcome in Temprano and HPTN052, and a secondary outcome in START
eSerious cardiovascular diseases were a component of the composite primary outcome in START and HPTN052, and a secondary outcome in Temprano
fThe trials analyses were adjusted for geographic regions (START) or study site (HPTN 052 and Temprano). In Temprano, Hazard Ratios were also adjusted for the IPT/no IPT treatment