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

TitleThe design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients.
Publication TypeJournal Article
Year of Publication2013
AuthorsZheng L, Rosenkranz SL, Taiwo B, Para MF, Eron JJ, Hughes MD
JournalAIDS Res Hum Retroviruses
Volume29
Issue4
Pagination652-7
Date Published2013 Apr
ISSN1931-8405
KeywordsAntiretroviral Therapy, Highly Active, Clinical Trials, Phase III as Topic, Confidence Intervals, HIV Infections, HIV-1, Humans, Randomized Controlled Trials as Topic, RNA, Viral, Treatment Failure, Treatment Outcome
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.

DOI10.1089/AID.2012.0180
Alternate JournalAIDS Res. Hum. Retroviruses
PubMed ID23228206
PubMed Central IDPMC3607972
Grant List1U01AI068634 / AI / NIAID NIH HHS / United States
1U01AI068636 / AI / NIAID NIH HHS / United States
P30 AI050410 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069423 / AI / NIAID NIH HHS / United States