title: Body composition changes after switching from protease inhibitors to raltegravir:  SPIRAL-LIP substudy.
abstract: OBJECTIVE
  To compare 48-week changes in body fat distribution and bone mineral density (BMD) between patients switching from a ritonavir-boosted protease inhibitor (PI/r) to raltegravir (RAL) and patients continuing with PI/r.
  
  
  METHODS
  Substudy of the prospective, randomized, open-label, multicenter SPIRAL study.
  
  
  METHODS
  Patients were randomized (1 : 1) to continue with the PI/r-based regimen or switch to RAL, maintaining the rest of the treatment unchanged. Dual-energy X-ray absorptiometry and computed tomography scans were performed at baseline and after 48 weeks to measure body fat and bone composition, analyzing intragroup and intergroup differences.
  
  
  RESULTS
  Eighty-six patients were included and 74 patients (39 RAL, 35 PI/r) completed the substudy. Significant increases in median [interquartile range (IQR)] visceral adipose tissue (VAT) [20.7 (-2.4 to 45.6) cm(2), P = 0.002] and total adipose tissue (TAT) [21.4 (-1.3 to 55.4) cm(2), P = 0.013] were seen within the PI/r group. No significant changes in body fat were seen with RAL or between treatment groups. Regarding bone composition, total BMD [0.01 (0 to 0.02) g/cm(2), P = 0.002], total hip BMD [0.01 (0 to 0.03) g/cm(2), P = 0.015] and total hip T score [0.12 (-0.05 to 0.21) SD, P = 0.004] significantly increased with RAL, with no significant changes within the PI/r group. Differences between treatment groups were significant in femoral neck BMD [0.01 (-0.02 to 0.02) g/cm(2), P = 0.032] and T score [0.01 (-0.18 to 0.18) SD, P = 0.016].
  
  
  CONCLUSIONS
  Although there were no significant changes in body fat between groups, maintaining a PI/r-based regimen was associated with a significant increase in VAT and TAT. Switching to RAL led to a significant increase in femoral neck BMD when comparing between groups.
authors: Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Infectious Diseases Department, Spain. acurran@vhebron.net
authors: Adrian
authors: A
authors: Curran
authors: Esteban
authors: E
authors: Martinez
authors: Maria
authors: M
authors: Saumoy
authors: Luis
authors: L
authors: del Rio
authors: Manuel
authors: M
authors: Crespo
authors: Maria
authors: M
authors: Larrousse
authors: Daniel
authors: D
authors: Podzamczer
authors: Joaquin
authors: J
authors: Burgos
authors: Montse
authors: M
authors: Lonca
authors: Pere
authors: P
authors: Domingo
authors: Jose Maria
authors: JM
authors: Gatell
authors: Esteban
authors: E
authors: Ribera
mesh_terms: D015502:Absorptiometry, Photon; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000273:Adipose Tissue / Q000000981:diagnostic imaging* / Q000187:drug effects; D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001823:Body Composition / Q000187:drug effects*; D050218:Body Fat Distribution; D015519:Bone Density / Q000187:drug effects; D005260:Female; D005272:Femur Neck / Q000000981:diagnostic imaging* / Q000187:drug effects; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D061466:Lopinavir / Q000009:adverse effects / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011760:Pyrrolidinones / Q000494:pharmacology* / Q000627:therapeutic use; D000068898:Raltegravir Potassium; D019438:Ritonavir / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D011760:Pyrrolidinones; D061466:Lopinavir; D000068898:Raltegravir Potassium; D019438:Ritonavir