title: The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients.
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.
authors.affiliation: Statistical Data Analysis Center, Harvard School of Public Health, Boston, MA 02115, USA. szheng@sdac.harvard.edu
authors.forename: Lu
authors.initials: L
authors.lastname: Zheng
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenkranz
authors.forename: Babafemi
authors.initials: B
authors.lastname: Taiwo
authors.forename: Michael F
authors.initials: MF
authors.lastname: Para
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hughes
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000706:statistics & numerical data; D016001:Confidence Intervals; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D006801:Humans; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D012367:RNA, Viral