Literature DB >> 23228206

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

Lu Zheng1, Susan L Rosenkranz, Babafemi Taiwo, Michael F Para, Joseph J Eron, Michael D Hughes.   

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.

Entities:  

Mesh：

Substances：

Year:  2013        PMID： 23228206      PMCID： PMC3607972          DOI： 10.1089/AID.2012.0180

Source DB:  PubMed          Journal:  AIDS Res Hum Retroviruses        ISSN： 0889-2229            Impact factor:   2.205


  11 in total

Review 1.  Update of the Drug Resistance Mutations in HIV-1.

Authors:  Victoria A Johnson; Francoise Brun-Vezinet; Bonaventura Clotet; Huldrych F Gunthard; Daniel R Kuritzkes; Deenan Pillay; Jonathan M Schapiro; Douglas D Richman
Journal:  Top HIV Med       Date:  2008-12

Review 2.  HIV clinical trial design for antiretroviral development: moving forward.

Authors:  Kirk M Chan-Tack; Kimberly A Struble; Nathalie Morgensztejn; Jeffrey S Murray; Roy Gulick; Ben Cheng; Ian Weller; Veronica Miller
Journal:  AIDS       Date:  2008-11-30       Impact factor: 4.177

3.  Bayesian design of single-arm phase II clinical trials with continuous monitoring.

Authors:  Valen E Johnson; John D Cook
Journal:  Clin Trials       Date:  2009-06       Impact factor: 2.486

4.  Optimal two-stage designs for phase II clinical trials.

Authors:  R Simon
Journal:  Control Clin Trials       Date:  1989-03

5.  An optimal three-stage design for phase II clinical trials.

Authors:  L G Ensign; E A Gehan; D S Kamen; P F Thall
Journal:  Stat Med       Date:  1994-09-15       Impact factor: 2.373

6.  Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262).

Authors:  Babafemi Taiwo; Lu Zheng; Sebastien Gallien; Roy M Matining; Daniel R Kuritzkes; Cara C Wilson; Baiba I Berzins; Edward P Acosta; Barbara Bastow; Peter S Kim; Joseph J Eron
Journal:  AIDS       Date:  2011-11-13       Impact factor: 4.177

7.  Prevalence of mutations associated with reduced antiretroviral drug susceptibility among human immunodeficiency virus type 1 seroconverters in the United States, 1993-1998.

Authors:  H Weinstock; R Respess; W Heneine; C J Petropoulos; N S Hellmann; C C Luo; C P Pau; T Woods; M Gwinn; J Kaplan
Journal:  J Infect Dis       Date:  2000-06-13       Impact factor: 5.226

8.  Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial.

Authors:  Roy M Gulick; Heather J Ribaudo; Cecilia M Shikuma; Christina Lalama; Bruce R Schackman; William A Meyer; Edward P Acosta; Jeffrey Schouten; Kathleen E Squires; Christopher D Pilcher; Robert L Murphy; Susan L Koletar; Margrit Carlson; Richard C Reichman; Barbara Bastow; Karin L Klingman; Daniel R Kuritzkes
Journal:  JAMA       Date:  2006-08-16       Impact factor: 56.272

9.  Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study.

Authors:  Martin Markowitz; Bach-Yen Nguyen; Eduardo Gotuzzo; Fernando Mendo; Winai Ratanasuwan; Colin Kovacs; Guillermo Prada; Javier O Morales-Ramirez; Clyde S Crumpacker; Robin D Isaacs; Lucinda R Gilde; Hong Wan; Michael D Miller; Larissa A Wenning; Hedy Teppler
Journal:  J Acquir Immune Defic Syndr       Date:  2007-10-01       Impact factor: 3.731

10.  Class-sparing regimens for initial treatment of HIV-1 infection.

Authors:  Sharon A Riddler; Richard Haubrich; A Gregory DiRienzo; Lynne Peeples; William G Powderly; Karin L Klingman; Kevin W Garren; Tania George; James F Rooney; Barbara Brizz; Umesh G Lalloo; Robert L Murphy; Susan Swindells; Diane Havlir; John W Mellors
Journal:  N Engl J Med       Date:  2008-05-15       Impact factor: 91.245
View more
  7 in total

1.  Exact p-values for Simon's two-stage designs in clinical trials.

Authors:  Guogen Shan; Hua Zhang; Tao Jiang; Hanna Peterson; Daniel Young; Changxing Ma
Journal:  Stat Biosci       Date:  2016-06-16

2.  Boundary problem in Simon's two-stage clinical trial designs.

Authors:  Guogen Shan; John J Chen; Changxing Ma
Journal:  J Biopharm Stat       Date:  2016-02-16       Impact factor: 1.051

3.  Optimal adaptive two-stage designs for early phase II clinical trials.

Authors:  Guogen Shan; Gregory E Wilding; Alan D Hutson; Shawn Gerstenberger
Journal:  Stat Med       Date:  2015-11-03       Impact factor: 2.373

4.  Adapting Simon's Two-Stage Design for Efficient Screening of Filovirus Vaccines in Non-Human Primates.

Authors:  Nancy A Niemuth; Carol L Sabourin; Lucy A Ward
Journal:  Vaccines (Basel)       Date:  2022-07-29

Review 5.  Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations.

Authors:  Lu Zheng; Camlin Tierney; Ronald J Bosch
Journal:  Curr HIV/AIDS Rep       Date:  2021-07-02       Impact factor: 5.495

6.  Intervention through Short Messaging System (SMS) and phone call alerts reduced HbA1C levels in ~47% type-2 diabetics-results of a pilot study.

Authors:  Kanakavalli K Kundury; Basavanagowdappa Hathur
Journal:  PLoS One       Date:  2020-11-17       Impact factor: 3.240

7.  Prevention of Pemetrexed-Induced Rash Using Low-Dose Corticosteroids: A Phase II Study.

Authors:  Takumi Sakurada; Hiroshi Nokihara; Tadashi Koga; Yoshito Zamami; Mitsuhiro Goda; Kenta Yagi; Hirofumi Hamano; Fuka Aizawa; Hirokazu Ogino; Seidai Sato; Yasushi Kirino; Hisatsugu Goto; Yasuhiko Nishioka; Keisuke Ishizawa
Journal:  Oncologist       Date:  2022-07-05       Impact factor: 5.837
  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.