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| Name | Class |
|---|---|
| Suneva Medical, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artefill | Experimental | Four treatment visits using Artefill dermal filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artefill dermal filler | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
6. Subject has thrombocytopenia or a bleeding diathesis. 7. Subject is pregnant, planning to become pregnant, or breastfeeding. 8..Subject has been treated with any of the following within the time intervals specified prior to start of their participation in the study: Bovine collagen-6 months Hyaluronic acid-6 months Calcium hydroxylapatite-6 months Polyacrylamide-at any time Polylactic acid- 6 months Permanent implant grafts at any time. 9. Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
10. Subject has a known hypersensitivity to lidocaine. 11. Subject has a history of allergies to any bovine collagen products. 12. Subject is undergoing or planning to undergo desensitization injections to meat products.
13. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
14. Subject has substance abuse, depression, or other issues that, according to the investigator's judgment, would interfere with conduct of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Pierone, Jr., M.D | AIDS Research and Treatment Center of the Treasure Coast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whole Family Health Center | Vero Beach | Florida | 32960 | United States |
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| ID | Term |
|---|---|
| D019904 | Polymethyl Methacrylate |
| ID | Term |
|---|---|
| D008768 | Methylmethacrylates |
| D011109 | Polymethacrylic Acids |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
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|
| 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. | 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. | 36 months |
| Artefill for the Treatment of HIV-associated Facial Lipoatrophy | To evaluate the acceptability and tolerability of Artefill injections as reported by subjects. | 36 months |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000180 | Acrylic Resins |
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |