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Letters
November 6, 2002

Underpowered Clinical Trials of Antiretroviral Treatment—Reply

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

In Reply: We agree with Drs Arribas and Pulido that insufficient statistical power may limit the conclusions drawn from a comparative clinical study and their value for treatment recommendations. However, we believe that the 2 studies1,2 they cited deserved to be cautiously mentioned in our recommendations because, despite limitations, they bring scientific information pertinent for discussing therapy with nevirapine in treatment-naive patients. In the COMBINE study,2,3 for instance, in which 142 patients were enrolled, the proportion of patients with plasma HIV-1 RNA level below detection limits after 1 year of therapy was 75% in the nevirapine-containing arm and 60% in the nelfinavir-containing arm,3 allowing the authors to conclude that "zidovudine/lamivudine/nevirapine is at least as effective as zidovudine/lamivudine/nelfinavir as first-line therapy."

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