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The Ethics of Switch/Simplify in Antiretroviral Trials: Non-Inferior or Just Inferior?

  • Andrew Carr mail,

    acarr@stvincents.com.au

    Affiliations: Clinical Research Program, Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia, HIV/Immunology/Infectious Diseases Unit, St Vincent's Hospital, Sydney, Australia

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  • Jennifer Hoy,

    Affiliations: Infectious Diseases Unit, Alfred Hospital, Melbourne, Australia, Department of Infectious Diseases, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia

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  • Anton Pozniak

    Affiliation: Chelsea and Westminster Hospital, London, United Kingdom

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  • Published: July 17, 2012
  • DOI: 10.1371/journal.pmed.1001240

About the Authors

Andrew Carr
Clinical Research Program, Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia
Andrew Carr
HIV/Immunology/Infectious Diseases Unit, St Vincent's Hospital, Sydney, Australia
Jennifer Hoy
Infectious Diseases Unit, Alfred Hospital, Melbourne, Australia
Jennifer Hoy
Department of Infectious Diseases, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia
Anton Pozniak
Chelsea and Westminster Hospital, London, United Kingdom

Corresponding Author

Email: acarr@stvincents.com.au

Competing Interests

AC is a member for the PLoS Medicine Editorial Board. AC has received research funding from Baxter, GlaxoSmithKline/ViiV Healthcare, Merck, and Pfizer; consultancy fees from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. AC is funded in part by a Practitioner Fellowship of the Australian National Health and Medical Research Council. AC (but not JH or AP) was an investigator in the SWITCHMRK trial; no author participated in the MONET trial. AC has recently received research funding for a clinical trial sponsored by Gilead Sciences. JH's institution has received research funding from GlaxoSmithKline/ViiV Healthcare, Gilead Sciences, and Merck; travel sponsorship from Gilead Sciences, Janssen-Cilag, and Merck; and JH has served on advisory boards for Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Janssen-Cilag, Merck, and Roche. AP has received consultancy fees from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche and has received research funding from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. No pharmaceutical company was involved in the writing of this paper or decision to publish.

Author Contributions

Wrote the first draft of the manuscript: AC. Contributed to the writing of the manuscript: AC JH AP. ICMJE criteria for authorship read and met: AC JH AP. Agree with manuscript results and conclusions: AC JH AP. Performed the initial study search: AP. Conceived and designed the analysis: AC JH AP.