title: Four-year follow-up of polyalkylimide gel use for the treatment of HIV-associated lipoatrophy.
abstract: OBJECTIVE
  To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled trial (RCT).
  
  
  METHODS
  Five patients were treated with PAIG in a pilot study, and 31 patients were subsequently enrolled in the RCT of immediate or delayed (12 weeks later) PAIG injections. Endpoints included proportion of participants with complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression, anxiety, and satisfaction scores. Infections were classified as "confirmed" if purulent material was extracted and/or an organism cultured. Infections were classified as "possible" if only clinical signs were present without purulent discharge or microbiologic confirmation.
  
  
  RESULTS
  Year 4 results were available for 5 pilot and 27 full-scale study participants. Delayed complications included 5 confirmed infections (15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No significant changes were observed between years 2 to 4 in patient-graded FLSS, QoL, depression, and anxiety scores. Whereas 94% of participants were satisfied with their overall treatment, only 69% were satisfied with PAIG treatment specifically.
  
  
  CONCLUSIONS
  Even though PAIG treatment was associated with delayed complications including high rates of infection and nodules, most patients were satisfied with the treatment.
authors.affiliation: Maple Leaf Medical Clinic, Toronto, Ontario, Canada. mona.loutfy@wchospital.ca
authors.forename: Mona R
authors.initials: MR
authors.lastname: Loutfy
authors.forename: Jason
authors.initials: J
authors.lastname: Brunetta
authors.forename: Colin
authors.initials: C
authors.lastname: Kovacs
authors.forename: Christina
authors.initials: C
authors.lastname: Diong
authors.forename: Molly
authors.initials: M
authors.lastname: Gamble
authors.forename: Tony
authors.initials: T
authors.lastname: Antoniou
authors.forename: Graham
authors.initials: G
authors.lastname: Smith
authors.forename: Roberta
authors.initials: R
authors.lastname: Halpenny
authors.forename: Ron
authors.initials: R
authors.lastname: Rosenes
authors.forename: Janet M
authors.initials: JM
authors.lastname: Raboud
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005145:Face / Q000473:pathology; D005260:Female; D005782:Gels; D039682:HIV-Associated Lipodystrophy Syndrome / Q000628:therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects
chemical_list: D000180:Acrylic Resins; D019380:Anti-HIV Agents; C470344:Bio-Alcamid; D005782:Gels