HIV-facial Lipoatrophy Clinical Trial
Official title:
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Artefill is an injectable facial filler device that is currently approved by the FDA for the correction of nasolabial folds. This study seeks to examine the use of Artefill in the treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the cheeks and temples.
The objectives of this study are:
To evaluate the long-term safety of Artefill injection volumes that are three to four times
greater (i.e. up to 30 ml) than the volume indicated in the FDA approved product label (i.e.
8.9 ml)subjects with HIV.
To evaluate any adverse events associated with the use of Artefill. To evaluate the Quality
of Life and body image benefit from Artefill treatment in patients with lipoatrophy.
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