Response to vicriviroc in treatment-experienced subjects, as determined by an enhanced-sensitivity coreceptor tropism assay: reanalysis of AIDS clinical trials group A5211.
The enhanced-sensitivity Trofile assay (Monogram Biosciences) was used to retest coreceptor use at both study screening and study entry for 118 treatment-experienced subjects in AIDS Clinical Trials Group A5211 who had CCR5-tropic (R5) virus detected by the original Trofile assay at study screening. Among 90 recipients of vicriviroc, a significantly (P< .001) greater mean reduction in HIV-1 RNA was observed in 72 subjects with R5 virus versus 15 subjects reclassified as having dual/mixed-tropic viruses at screening: -1.11 versus -0.09 log(10) copies/mL at day 14 and -1.91 versus -0.57 log(10) copies/mL at week 24, respectively. Results suggest that the enhanced-sensitivity assay is a better screening tool for determining patient eligibility for CCR5 antagonist therapy.
Su
Zhaohui
Z
Harvard School of Public Health, Boston, Massachusetts 02115, USA. zsu@sdac.harvard.edu
Gulick
Roy M
RM
Krambrink
Amy
A
Coakley
Eoin
E
Hughes
Michael D
MD
Han
Dong
D
Flexner
Charles
C
Wilkin
Timothy J
TJ
Skolnik
Paul R
PR
Greaves
Wayne L
WL
Kuritzkes
Daniel R
DR
Reeves
Jacqueline D
JD
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D065100:CCR5 Receptor Antagonists; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000378:metabolism / Q000502:physiology*; D006801:Humans; D010879:Piperazines / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D012367:RNA, Viral / Q000378:metabolism; D012680:Sensitivity and Specificity; D018709:Statistics, Nonparametric; D056189:Viral Tropism / Q000187:drug effects / Q000502:physiology
D019380:Anti-HIV Agents; D065100:CCR5 Receptor Antagonists; D010879:Piperazines; D011743:Pyrimidines; D012367:RNA, Viral; C486781:vicriviroc