Format

Send to

Choose Destination
See comment in PubMed Commons below
AIDS Res Hum Retroviruses. 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.

Author information

1
Statistical Data Analysis Center, Harvard School of Public Health, Boston, MA 02115, USA. szheng@sdac.harvard.edu

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.

PMID:
23228206
PMCID:
PMC3607972
DOI:
10.1089/AID.2012.0180
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Mary Ann Liebert, Inc. Icon for PubMed Central
    Loading ...
    Support Center