The rationale and design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) 058 FIRST (Flexible Initial Retrovirus Suppressive Therapies) trial.
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. Control Clin Trials 2001;22:176-190
MacArthur
R D
RD
University Health Center, Wayne State University, 4201 St. Antoine, UHC 7-D, Detroit, MI 48201, USA. rmacarthur@intmed.wayne.edu
Chen
L
L
Mayers
D L
DL
Besch
C L
CL
Novak
R
R
van den Berg-Wolf
M
M
Yurik
T
T
Peng
G
G
Schmetter
B
B
Brizz
B
B
Abrams
D
D
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D000465:Algorithms; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D011480:Protease Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D018401:Sample Size
D011480:Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors