OBJECTIVE: To review the clinical data for poly-L-lactic acid, a synthetic polymer used as an intradermal injection for the treatment of HIV associated facial fat loss (lipoatrophy). DATA SOURCES: A literature search was performed using MEDLINE (1966-August 2006). The search was limited to articles published in English and used the key words polylactic acid, polylactides, degradation, lipodystrophy, lipoatrophy, and HIV/AIDS. Dermik Laboratories was contacted to obtain unpublished information. Additional articles were retrieved from citations of selected references. STUDY SELECTION AND DATA EXTRACTION: Relevant information on the pharmacology, pharmacokinetics, safety, and efficacy of poly-L-lactic acid from clinical trials were selected. DATA SYNTHESIS: Poly-L-lactic acid (Sculptra) is a biocompatible, biodegradable, synthetic polymer able to be tailored into various desired morphologic features. It is approved by the Food and Drug Administration for the correction of facial lipoatrophy in people with HIV. Six clinical trials have evaluated the use of intradermal injections of poly-L-lactic acid. Results showed that cutaneous thickness is improved in patients receiving poly-L-lactic acid. Adverse effects included nodule and hematoma formation, as well as pain at the injection site. CONCLUSIONS: Poly-L-lactic acid offers a treatment alternative for patients with HIV-associated lipoatrophy. Further research is required in nonwhite populations.
OBJECTIVE: To review the clinical data for poly-L-lactic acid, a synthetic polymer used as an intradermal injection for the treatment of HIV associated facial fat loss (lipoatrophy). DATA SOURCES: A literature search was performed using MEDLINE (1966-August 2006). The search was limited to articles published in English and used the key words polylactic acid, polylactides, degradation, lipodystrophy, lipoatrophy, and HIV/AIDS. Dermik Laboratories was contacted to obtain unpublished information. Additional articles were retrieved from citations of selected references. STUDY SELECTION AND DATA EXTRACTION: Relevant information on the pharmacology, pharmacokinetics, safety, and efficacy of poly-L-lactic acid from clinical trials were selected. DATA SYNTHESIS: Poly-L-lactic acid (Sculptra) is a biocompatible, biodegradable, synthetic polymer able to be tailored into various desired morphologic features. It is approved by the Food and Drug Administration for the correction of facial lipoatrophy in people with HIV. Six clinical trials have evaluated the use of intradermal injections of poly-L-lactic acid. Results showed that cutaneous thickness is improved in patients receiving poly-L-lactic acid. Adverse effects included nodule and hematoma formation, as well as pain at the injection site. CONCLUSIONS:Poly-L-lactic acid offers a treatment alternative for patients with HIV-associated lipoatrophy. Further research is required in nonwhite populations.