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Table 2 Main outcomes of the three early ART randomized controlled trials (HPTN052, Temprano ANRS 12136, START)

From: Antiretroviral treatment regardless of CD4 count: the universal answer to a contextual question

  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)
  1. N number of participants who had at least one such type of outcome; ART antiretroviral treatment; NA non available; PY person-years
  2. aComponent of the composite primary outcome in the three trials
  3. 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)
  4. cCervical carcinoma, Kaposi’s sarcoma, Lymphoma, Hodgkin’s, Lymphoma, non-Hodgkin’s non-AIDS cancers
  5. dInvasive bacterial diseases were a component of the composite primary outcome in Temprano and HPTN052, and a secondary outcome in START
  6. eSerious cardiovascular diseases were a component of the composite primary outcome in START and HPTN052, and a secondary outcome in Temprano
  7. 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