title: Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial.
abstract: OBJECTIVE
  To compare the outcome of highly active antiretroviral therapy (HAART) in HIV-infected patients initiating equivalent regimens within and outside a randomized controlled trial (RCT).
  
  
  METHODS
  The Danish Protease Inhibitor Study (DAPIS) was a national multicenter RCT comparing initial treatment with indinavir, ritonavir, or saquinavir/ritonavir during 96 weeks. From the Danish HIV Cohort Study we identified all patients initiating one of these protease-inhibitor-based HAART regimens: 425 patients within DAPIS and 677 outside the trial. We compared viral load, CD4 count response, and mortality.
  
  
  RESULTS
  At weeks 96 and 240, trial participants were more likely than nonparticipants to have undetectable viral load (adjusted odds ratio [adOR] 1.28 [95% CI=0.94-1.74] and 1.70 [95% CI=1.16-2.50]) and a CD4 increase > or =100 cells/microl (adOR 1.37 [95% CI=1.03-1.82] and 1.53 [95% CI=1.04-2.25]). For antiretroviral-experienced, but not for antiretroviral-naïve patients, trial participants had a lower risk of death (mortality rate ratio [MRR]=0.46 [95% CI=0.27-0.77]) than nonparticipants. This effect was moderated in adjusted analyses (MRR=0.60 [0.33-1.07]).
  
  
  CONCLUSIONS
  Compared to nontrial patients, trial participants had better response to HAART. The differences were small defying the notion that results obtained in RCTs are unachievable in routine clinical practice.
authors: Department of Infectious Diseases, Odense University Hospital, Kløvervaenget 2, Odense C, Denmark. ann-brit.eg.hansen@rh.hosp.dk
authors: Ann-Brit Eg
authors: AB
authors: Hansen
authors: Jan
authors: J
authors: Gerstoft
authors: Ole
authors: O
authors: Kirk
authors: Lars
authors: L
authors: Mathiesen
authors: Court
authors: C
authors: Pedersen
authors: Henrik
authors: H
authors: Nielsen
authors: Søren
authors: S
authors: Jensen-Fangel
authors: Henrik Toft
authors: HT
authors: Sørensen
authors: Niels
authors: N
authors: Obel
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015986:Confounding Factors, Epidemiologic; D004812:Epidemiologic Methods; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors