SLOAT

Soriano V. J Antimicrob Chemother. 2008 Jan;61(1):200-5

Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch to ATV or ATV-r
» ATV + 2 NRTI or ATV/r + 2 NRTI vs LPV/r + 2 NRTI
Drugs
ATV/r, ATV, LPV/r, 2 NRTI

DOWNLOAD THIS SLIDE KIT

  • For patients with undetectable viraemia on a stable LPV/r-based regimen, replacement of LPV/r by ATV+r may provide:
    • An overall reduction in fasting cholesterol and triglycerides
    • No increased risk of virologic failure

Design :

Objective :

  • Non inferiority in the proportion of patients with virologic rebound at W48 (upper limit of the 95% CI for the difference = 90%, 90% power)
  • Virologic rebound: HIV-1 RNA > 50 c/mL

Baseline characteristics and patient disposition :

  • PI use at screening was LPV/r: 37%, NFV: 33%, IDV/r: 10%, IDV: 8%, SQV/r: 6%, SQV: 3%
  • TDF was part of the ARV regimen in 37 patients (9%) [26 in the ATV group]

Results: W48 outcome

Virologic failure

  • Resistance mutations at virologic failure
    • LPV/r: 1/9
    • ATV: 2/5
    • ATV/r: 3/7
  • Median ATV Ctrough *
    • ATV/r: 0.822 mg/L
    • ATV: 0.234 mg/L
  • Median CD4 increase between baseline and W48
    • LPV/r: 46/mm3
    • ATV+r: 42/mm3

* Effective minimal Ctrough = 0.15 mg/L

Metabolic parameters :

Use of lipid-lowering agents was more frequent in the LPV/r group: 17% vs 5% (p = 0.006)