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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Four treatment visits will be scheduled at baseline and at weeks 4, 12, and 24. Each treatment session will utilize no more than 8 mL of Artefill and no more than 30 syringes of Artefill.
Whole Family Health Center
Vero Beach, Florida, United States
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
To evaluate the effectiveness of Artefill injections as a long-term treatment for human immunodeficiency virus (HIV)-associated facial lipoatrophy over 36 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre/post intervention photography.
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the safety of Artefill injections as a long-term treatment for HIV-associated facial lipoatrophy over 36 months by monitoring the incidence of adverse events.
Time frame: 36 months
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
To evaluate the effectiveness of Artefill injections as a long-term treatment for HIV-associated facial lipoatrophy over 36 months by assessing changes in the Modified James Scale grade based on assessment of pre/post intervention photography by 2 blinded physicians.
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the effects of Artefill injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the effects of Artefill injections on the subject's psychological well-being using the Medical Outcomes study-HIV (MOS-HIV)assessment.
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.
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Time frame: 36 months