1. NRTI-sparing SPARTAN PROGRESS RADAR NEAT001/ANRS 143 A4001078 VEMAN
ARV-trial.com
NRTI-sparing
SPARTAN
PROGRESS
RADAR
NEAT001/ANRS 143 A
VEMAN
MODERN 1

2. VEMAN Study: LPV/r + MVC vs LPV/r + TDF/FTC
118
Randomisation
1 : 1
Open-label
Design
W48
Adults
HIV+
Antiretroviral naïve
HIV-1 RNA ≥ c/mL
CD4 ≥ 100/mm3
CCR5-tropic (Trofile®)
No resistance to TDF, FTC or LPV
HBV co-infection excluded
N = 26
LPV/r 400/100 bid + MVC 150 qd
LPV/r + TDF/FTC
N = 24
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
VEMAN
Nozza S. Clin Microb Infection 2015;21:510.e1-e9

3. VEMAN Study: LPV/r + MVC vs LPV/r + TDF/FTC
Baseline characteristics (median), and disposition
LPV/r + MVC
N = 26
LPV/r + TDF/FTC
N = 24
Age, years 39
Female 4%
CD4/mm3
295
292
HIV RNA, log10 copies/mL
4.41
4.42
Discontinuation by W48
N = 2 (diarrhea)
N = 3 (diarrhea)
Virologic efficacy and immunologic response
LPV/r + MVC
LPV/r + TDF/FTC p
Median HIV RNA decrease at W24 (log10 c/mL)
- 2.86
-2.45
0.089
Median HIV RNA decrease at W48 (log10 c/mL)
-2.78
0.262
HIV RNA < 50 c/mL at W48
100%
91.7%
0.225
Change in CD4/mm3 at W48
+ 286
+ 199
0.033
Change in CD4+ effector memory cells at W48
+ 1.6%
- 4.4%
0.001
VEMAN
Nozza S. Clin Microb Infection 2015;21:510.e1-e9

4. VEMAN Study: LPV/r + MVC vs LPV/r + TDF/FTC
Conclusion
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
VEMAN
Nozza S. Clin Microb Infection 2015;21:510.e1-e9