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Table 1 Main characteristics 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

 

HPTN052

Temprano

START

First enrolment–last visit

June 2007–May 2011

March 2008–Jan 2015

April 2009–May 2015

 Protocol

  Study design

Open label RCT

Open label RCT

Open label RCT

  CD4 inclusion criterion

350 < CD4 < 550

250/350 < CD4 < 800b

>500

  ART initiation CD4 thresholda

250

200–350–500b

350

  Composite primary outcome

Death, WHO stage 4, non-AIDS cancers, tuberculosis, severe bacterial infections, serious cardiovascular, diabetes mellitus

Death, AIDS, non AIDS cancers severe bacterial infections

Death, AIDSc, non AIDS cancer, serious cardiovasculard, renal failure, liver failure

 Number of participants

  Enrolled/analyzed

1763/1761

2076/2056

4588/4585

   Early ART

886

1033

2326

   Deferred ART

875

1023

2359

  Geographical origin

   Africa

54 %

100 %

21 %

   Europe, USA, Australia, Israel

–

–

46 %

   Asia

30 %

–

7 %

   Latin America

16 %

–

25 %

 Baseline characteristics

  % of women

49 %

79 %

27 %

  Age, median (IQR)

33 (27–39)

35 (29–42)

36 (29–44)

  CD4 count, median (IQR; Max)

436 (364–522; 550)

463 (366–572; 1456e)

651 (584–765; 2296)

  Positive serum HBs Ag

5 %

9 %

NA

 Follow-up characteristics

  Received IPT during trial follow-up, %

3 %

45 %

NA

  Follow-up, year, median (IQR)

2.1 (1.5–2.9)

2.5 (2.5–2.5)

2.8 (2.1–3.9)

  1. RCT randomized controlled trial; IPT isoniazid prophylaxis for tuberculosis
  2. aART-start CD4 threshold for asymptomatic patients randomized to the deferred ART strategy
  3. bFor ethical reasons, the Temprano investigators considered that the WHO revised guidelines had to be followed as soon as they were released
  4. Therefore, they adopted the WHO 2010 guidelines in December 2009 as soon as the WHO rapid advice was released; and further adopted the WHO 2013 guidelines in August 2013. The 2010 and 2013 guidelines revisions impacted the trial procedures at two levels: the eligibility criterion ‘no WHO criteria for starting ART’, and the criteria for starting ART in participants assigned to the Deferred-ART strategy:
  5. Asymptomatic patients were considered having ‘no WHO criteria for starting ART’ and therefore eligible for the trial: between the trial start and November 2009: if they had more than 250 CD4/mm3; Between December 2009 and July 2012: if they had more than 350 CD4/mm3; As enrolment was completed in July 2012, the WHO 2013 guidelines revision did not impact the eligibility criteria
  6. Asymptomatic participants assigned to the Deferred-ART strategy started ART: between the trial start and November 2009: whenever they met the WHO 2006 criteria for starting ART (CD4 count <200/mm3); Between December 2009 and July 2013: whenever they met the WHO 2010 criteria for starting ART (CD4 count <350/mm3); Between August 1st 2013: whenever they met the WHO 2013 criteria for starting ART (CD4 count <500/mm3; or stable partnership with an HIV-negative individual)
  7. cExcluding HSV and oesophageal candidiasis
  8. dMyocardial infarction, stroke, or coronary revascularization
  9. eTemprano, patients were eligible for the trial if the pre-inclusion CD4 count (measured within 1 months prior to randomization) was below 800/mm3. The “baseline” CD4 count distribution shown here is the distribution of values measured at inclusion (ie after informed consent), not the pre-inclusion value that determined eligibility. This explains why some patients had CD4 counts higher than 800/mm3 at baseline
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AIDS Research and Therapy

ISSN: 1742-6405

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