title: Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.
abstract: BACKGROUND
  Fat gain after antiretroviral therapy (ART) occurs, and its association with protease inhibitors (PIs) is unclear.
  
  
  METHODS
  Peripheral and central fat depots and lean mass were measured using standardized and centrally read abdominal CT scans and whole-body dual-energy absorptiometry scans over a 96-week period in human immunodeficiency virus (HIV)-infected treatment-naive participants. The patients were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or raltegravir (RAL) in ACTG A5260s, a substudy of A5257. Within arm changes were assessed with signed-rank tests. The 96-week percentage changes in fat and lean mass in the 2 PI arms were not different, thus the PI arms were combined and compared to the RAL arm. Associations between baseline biomarkers and changes in body composition were assessed. All analyses used linear regression models.
  
  
  RESULTS
  328 patients were randomized (90% male, 44% white non-Hispanic). The median age was 36 years, HIV-1 RNA 4.6 log10 copies/mL, and CD4 349 cells/μL. Overall, at week 96, increases in limb fat (13.4%), subcutaneous (19.9%) and visceral abdominal fat (25.8%), trunk fat (18%), and lean mass (1.8%) were apparent (P < .001 for changes within each arm). Changes for all fat and lean outcomes were not different between the PI arms or between the RAL and the combined PI arms. Higher baseline HIV-1 RNA levels were associated with greater gains in peripheral and central fat.
  
  
  CONCLUSIONS
  In treatment-naive participants initiating ART with TDF/FTC, no differences in lean mass and regional fat were found with RAL when compared with ATV/r or DRV/r over 96 weeks.
  
  
  BACKGROUND
  NCT00811954 and NCT00851799.
authors.affiliation: Case Western Reserve University, Cleveland, Ohio.
authors.forename: Grace A
authors.initials: GA
authors.lastname: McComsey
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Carlee
authors.initials: C
authors.lastname: Moser
authors.affiliation: Univeristy of California-Los Angeles.
authors.forename: Judith
authors.initials: J
authors.lastname: Currier
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Ribaudo
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Pawel
authors.initials: P
authors.lastname: Paczuski
authors.affiliation: University of Southern California Keck School of Medicine, Los Angeles.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Dubé
authors.affiliation: Univeristy of California-Los Angeles.
authors.forename: Theodoros
authors.initials: T
authors.lastname: Kelesidis
authors.affiliation: Social & Scientific Systems, Inc., Silver Spring, Maryland.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rothenberg
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison.
authors.forename: James H
authors.initials: JH
authors.lastname: Stein
authors.affiliation: Johns Hopkins University, Baltimore, Maryland.
authors.forename: Todd T
authors.initials: TT
authors.lastname: Brown
mesh_terms: D050153:Abdominal Fat / Q000187:drug effects*; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001823:Body Composition / Q000187:drug effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011480:Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium / Q000009:adverse effects* / Q000627:therapeutic use; D019562:Viral Load / Q000187:drug effects; D015430:Weight Gain / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D011480:Protease Inhibitors; D012367:RNA, Viral; D000068898:Raltegravir Potassium
keywords: body composition; limb fat; lipodystrophy; lipoatrophy; visceral fat