PMID- 16494632
OWN - NLM
STAT- MEDLINE
DCOM- 20060915
LR  - 20161124
IS  - 1464-2662 (Print)
IS  - 1464-2662 (Linking)
VI  - 7
IP  - 3
DP  - 2006 Apr
TI  - Long-term safety and efficacy of poly-L-lactic acid in the treatment of 
      HIV-related facial lipoatrophy.
PG  - 181-5
AB  - OBJECTIVE: We evaluated the long-term safety and efficacy of injectable 
      poly-L-lactic acid (PLLA) for the correction of facial lipoatrophy. METHODS: This 
      was a randomized, open-label, comparative, single-centre study of injected PLLA 
      in patients with HIV-related facial lipoatrophy. Thirty subjects were randomized 
      to immediate or delayed PLLA treatments, administered as three sets of bilateral 
      injections, 2 weeks apart, into the deep dermis above the buccal fat pad. Week 24 
      results have been published previously (Moyle et al, HIV Medicine 2004, Vol. 5, 
      pp. 82-87). Long-term efficacy was assessed at a recall visit using visual 
      analogue scales (VASs) to record patient satisfaction, and by the Hospital 
      Anxiety and Depression Scale (HADS). Patients also reported any adverse events 
      (AEs) during the treatment period and at the recall visit. RESULTS: Twenty-seven 
      patients returned for the recall visit, a minimum of 18 months post final study 
      treatment. Fourteen of these patients were excluded from the recall visit because 
      of additional treatment with PLLA. Improvements in VAS scores for facial 
      appearance were sustained from baseline to the recall visit in both randomization 
      groups (P<0.05 and P<0.001). Trends in improvement in HADS scores were also 
      noted, with patients in the delayed group experiencing significant improvements 
      in depressive symptoms (P<0.05). One case of injection-site induration and nine 
      cases of injection-site nodules were noted at the recall visit, none of which was 
      described as serious or severe. CONCLUSIONS: Physical and psychological benefits 
      of PLLA are sustained over at least 18 months. Delayed AEs include mild 
      nodularity at the treatment site.
FAU - Moyle, G J
AU  - Moyle GJ
AD  - Department of HIV Medicine, Chelsea and Westminster Hospital, London, UK. 
      gm@moyleg.demon.co.uk
FAU - Brown, S
AU  - Brown S
FAU - Lysakova, L
AU  - Lysakova L
FAU - Barton, S E
AU  - Barton SE
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
RN  - 0 (Biocompatible Materials)
RN  - 0 (Drug Implants)
RN  - 0 (Polyesters)
RN  - 0 (Polymers)
RN  - 33X04XA5AT (Lactic Acid)
RN  - 459TN2L5F5 (poly(lactide))
SB  - IM
MH  - Adult
MH  - Biocompatible Materials/*administration & dosage/adverse effects
MH  - *Cosmetic Techniques/adverse effects
MH  - Drug Implants
MH  - *Face
MH  - Female
MH  - Follow-Up Studies
MH  - *HIV-1
MH  - HIV-Associated Lipodystrophy Syndrome/*therapy
MH  - Humans
MH  - Injections
MH  - Lactic Acid/*administration & dosage/adverse effects
MH  - Male
MH  - Pilot Projects
MH  - Polyesters
MH  - Polymers/*administration & dosage/adverse effects
MH  - Safety
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
EDAT- 2006/02/24 09:00
MHDA- 2006/09/16 09:00
CRDT- 2006/02/24 09:00
PHST- 2006/02/24 09:00 [pubmed]
PHST- 2006/09/16 09:00 [medline]
PHST- 2006/02/24 09:00 [entrez]
AID - HIV342 [pii]
AID - 10.1111/j.1468-1293.2006.00342.x [doi]
PST - ppublish
SO  - HIV Med. 2006 Apr;7(3):181-5. doi: 10.1111/j.1468-1293.2006.00342.x.