Skip Navigation LinksHome > December 15, 2007 - Volume 46 - Issue 5 > A Randomized, Multicenter, Open-Label Study of Poly-L-Lactic...
JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318158bec9
Clinical Science

A Randomized, Multicenter, Open-Label Study of Poly-L-Lactic Acid for HIV-1 Facial Lipoatrophy

Carey, Dianne L MPH*; Baker, David MB, ChB†; Rogers, Gary D MBBS, PhD‡; Petoumenos, Kathy PhD*; Chuah, John MBBS, BSc (Med) Hons§; Easey, Nicole BApplSc (Med Imaging)∥; Machon, Kirsty BA (Hons), MA¶; Cooper, David A DSc, MD*∥; Emery, Sean PhD*; Carr, Andrew MD∥; for the Facial LipoAtrophy Study in HIV Investigators

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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.

© 2007 Lippincott Williams & Wilkins, Inc.

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