The rationale and design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) trial

Rodger David MacArthur, Li Chen, Douglas L. Mayers, C. Lynn Besch, Richard Novak, Mary Van Den Berg-Wolf, Teresa Yurik, Grace Peng, Barry Schmetter, Barbara Brizz, Donald Abrams

Research output: Contribution to journalArticle

28 Scopus citations

Abstract

The CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) trial is a large, long-term, randomized, prospective comparison of three different antiretroviral strategies in highly active antiretroviral therapy-naïve, HIV-1-infected persons. The trial was designed as a flexible framework upon which other studies could be added to answer more limited, but still important, questions. This article presents the study design, discusses the challenges we have faced in implementing the trial, and describes our preliminary experiences.

Original languageEnglish (US)
Pages (from-to)176-190
Number of pages15
JournalControlled Clinical Trials
Volume22
Issue number2
DOIs
Publication statusPublished - Apr 23 2001
Externally publishedYes

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Keywords

  • AIDS
  • Antiretroviral
  • Clinical trial design
  • Phase III study
  • Strategy

ASJC Scopus subject areas

  • Pharmacology

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