Work

The Design of Single-Arm Clinical Trials of Combination Antiretroviral Regimens for Treatment-Naive HIV-Infected Patients

Year: 2012

Type: article

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.

Source: AIDS Research and Human Retroviruses

DOI: 10.1089/aid.2012.0180

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

Institutions: Harvard University, Northwestern University, The Ohio State University, University of North Carolina at Chapel Hill

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institutes of Health, National Institute of Allergy and Infectious Diseases