Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
Arribas JR, Pulido F. Underpowered Clinical Trials of Antiretroviral Treatment. JAMA. 2002;288(17):2120-2121. doi:10.1001/jama.288.17.2118