title: A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy.
abstract: BACKGROUND
  Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.
  
  
  METHODS
  HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.
  
  
  RESULTS
  At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.
  
  
  CONCLUSIONS
  PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.
authors.affiliation: National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia. dcarey@nchecr.unsw.edu.au
authors.forename: Dianne L
authors.initials: DL
authors.lastname: Carey
authors.forename: David
authors.initials: D
authors.lastname: Baker
authors.forename: Gary D
authors.initials: GD
authors.lastname: Rogers
authors.forename: Kathy
authors.initials: K
authors.lastname: Petoumenos
authors.forename: John
authors.initials: J
authors.lastname: Chuah
authors.forename: Nicole
authors.initials: N
authors.lastname: Easey
authors.forename: Kirsty
authors.initials: K
authors.lastname: Machon
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Sean
authors.initials: S
authors.lastname: Emery
authors.forename: Andrew
authors.initials: A
authors.lastname: Carr
mesh_terms: D005145:Face / Q000000981:diagnostic imaging / Q000473:pathology*; D005260:Female; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D012720:Severity of Illness Index; D050151:Subcutaneous Fat / Q000473:pathology*
chemical_list: D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)