TY  - JOUR
T1  - UNderpowered clinical trials of antiretroviral treatment—reply
AU  - Yeni PG, Hammer SM, et al
Y1  - 2002/11/06
N1  - 10.1001/jama.288.17.2118
JO  - JAMA
SP  - 2120
EP  - 2121
VL  - 288
IS  - 17
N2  - 
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."

SN  - 0098-7484
M3  - doi: 10.1001/jama.288.17.2118
UR  - http://dx.doi.org/10.1001/jama.288.17.2118
ER  -