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November 6, 2002

Underpowered Clinical Trials of Antiretroviral Treatment

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

JAMA. 2002;288(17):2120-2121. doi:10.1001/jama.288.17.2118

To the Editor: Dr Yeni and colleagues make the following 2 statements about underpowered trials in describing updated recommendations of the International AIDS Society-USA Panel for the treatment of adult HIV infection1: (1) "Nevirapine has been studied in the ATLANTIC trial . . . . Although not powered to provide definitive conclusions, the results suggested that activity of nevirapine in a multidrug regimen was similar to that of indinavir." (2) "Comparability in viral suppression at 36 weeks between nevirapine-containing and nelfinavir-containing regimens (each with 2 nRTIs [nucleoside reverse transcriptase inhibitors) has been reported." In our opinion, both statements are misleading. In addition to other concerns about underpowered trials,2 such results may also be used to support questionable therapeutic practices.

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