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J Clin Epidemiol. 2008 Jan;61(1):87-94. Epub 2007 Aug 3.

Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial.

Author information

  • 1Department of Infectious Diseases, Odense University Hospital, Kløvervaenget 2, Odense C, Denmark. ann-brit.eg.hansen@rh.hosp.dk

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).

STUDY DESIGN AND SETTING:

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.

PMID:
18083465
[PubMed - indexed for MEDLINE]
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