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

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

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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Antiretroviral Therapy, Highly Active / methods*
  • Clinical Trials, Phase III as Topic / methods*
  • Clinical Trials, Phase III as Topic / statistics & numerical data
  • Confidence Intervals
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1
  • Humans
  • RNA, Viral / blood
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Treatment Failure
  • Treatment Outcome

Substances

  • RNA, Viral