Skip to main content

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