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

Lu Zheng; Susan L. Rosenkranz; Babafemi Taiwo; Michael F. Para; Joseph J. Eron; Michael D. Hughes

doi:10.1089/aid.2012.0180

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

Lu Zheng^*, Susan L. Rosenkranz, Babafemi Taiwo, Michael F. Para, Joseph J. Eron, Michael D. Hughes

^*Corresponding author for this work

Medicine, Infectious Diseases Division

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

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.

Original language	English (US)
Pages (from-to)	652-657
Number of pages	6
Journal	AIDS research and human retroviruses
Volume	29
Issue number	4
DOIs	https://doi.org/10.1089/aid.2012.0180
State	Published - Apr 1 2013

ASJC Scopus subject areas

Infectious Diseases
Virology
Immunology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1089/aid.2012.0180

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

Abstract

ASJC Scopus subject areas

UN SDGs

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