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

Research output: Contribution to journalArticle

5 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 languageEnglish (US)
Pages (from-to)652-657
Number of pages6
JournalAIDS research and human retroviruses
Volume29
Issue number4
DOIs
StatePublished - Apr 1 2013

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Infectious Diseases

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