VEMAN Study: LPV/r + MVC vs LPV/r + TDF/FTC

Nozza S. Clin Microbiol Infect. 2015 May;21(5):510

Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» 2 drugs vs 3 drugs
» NRTI-Sparing
» LPV/r + MVC vs LPV/r + FTC/TDF
Drugs
MVC, LPV/r, FTC/TDF, TDF, FTC

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  • Among naive patients with an R5 virus, treatment with MVC and LPV/r was shown to provide a virological response compared to a triple therapy and a greater immunological benefit
  • Limitations
    • Small sample size
    • Unpowered to establish non-inferiority
    • AEs self-reported, open-label unblinded design

Design

Objective

  • Primary endpoint: 12-week change of HIV-1 RNA from baseline (ITT analysis), difference between groups assessed by the Wilcoxon signed rank test, no formal statistical hypothesis
  • Viral rebound: 2 consecutive HIV RNA > 50 copies/mL

Baseline characteristics (mean), and disposition

Virologic efficacy and immunologic response