Document Detail


Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial.
MedLine Citation:
PMID:  18083465     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Ann-Brit Eg Hansen; Jan Gerstoft; Ole Kirk; Lars Mathiesen; Court Pedersen; Henrik Nielsen; Søren Jensen-Fangel; Henrik Toft Sørensen; Niels Obel
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2007-08-03
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  61     ISSN:  0895-4356     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  2008 Jan 
Date Detail:
Created Date:  2007-12-17     Completed Date:  2008-03-11     Revised Date:  2008-06-24    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  England    
Other Details:
Languages:  eng     Pagination:  87-94     Citation Subset:  IM    
Affiliation:
Department of Infectious Diseases, Odense University Hospital, Kløvervaenget 2, Odense C, Denmark. ann-brit.eg.hansen@rh.hosp.dk
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MeSH Terms
Descriptor/Qualifier:
Adult
Antiretroviral Therapy, Highly Active*
CD4 Lymphocyte Count
Confounding Factors (Epidemiology)
Epidemiologic Methods
Female
HIV Infections / drug therapy*,  immunology,  virology
HIV Protease Inhibitors / therapeutic use
Humans
Male
Middle Aged
Randomized Controlled Trials as Topic*
Treatment Outcome
Viral Load
Chemical
Reg. No./Substance:
0/HIV Protease Inhibitors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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