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. 2013 Apr;29(4):652-7.
doi: 10.1089/AID.2012.0180. Epub 2013 Jan 9.

The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients

Lu Zheng  1 , Susan L Rosenkranz, Babafemi Taiwo, Michael F Para, Joseph J Eron Jr, Michael D Hughes
Affiliations

The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients

Lu Zheng et al. AIDS Res Hum Retroviruses. 2013 Apr.

Abstract

Single-arm clinical trials are useful to evaluate antiretroviral regimens in certain populations of HIV-infected treatment-naive patients for whom a randomized controlled trial is not feasible or desirable. They can also be useful to establish initial estimates of efficacy and safety/tolerability of novel regimens to inform the design of large phase III trials. In this article, we discuss key design considerations for such single-arm studies.

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Figures

FIG. 1.
FIG. 1.
Representative hypothetical confidence intervals achieved at the end of the single-arm study and how each is interpreted.
FIG. 2.
FIG. 2.
Operating characteristics of two-sided 95% confidence interval for a failure rate threshold of 35% for sample sizes of 50, 100, and 150 participants.
See this image and copyright information in PMC

References

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