Artefill for the Treatment of HIV-associated Facial Lipoatrophy

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.

Inclusion Criteria:

1. Subject is male or female between 18-80 years of age inclusive at the time of signing
the informed consent.

2. Subject desires treatment for facial volume loss.

3. Subject has HIV infection with moderated to severe facial lipoatrophy based on the
Modified James Scale grades II-IV.

4. Subject has viral load <400 copies/mL.

5. Subject has CD4 lymphocyte counts >200/mm.

6. Subject has documented negative Artefill skin test or has received treatment with
Artefill in the past without evidence of hypersensitivity reaction.

7. Subject is willing to withhold additional aesthetic implant therapies (eg, other soft
tissue fillers such as Restylane, silicone, Radiesse, Sculptra or implants such as
Gortex, Silastic, etc) for the duration of the study.

Exclusion Criteria:

1. Subject has any skin pathology, inflammatory skin disease, or condition that could
interfere with the evaluation of the treatment areas.

2. Subject has a history of systemic granulomatous diseases (sarcoid, Wegeners, etc) or
connective tissue disease (lupus, dermatomyositis, ect)

3. Subject has history of keloid formation or hypertrophic scarring.

4. Subject has a history of malignancy (other than skin cancer) within 12 months of
enrollment. 5.Subject has been treated with systemic corticosteroids(eg, prednisone)
or interferon within 1 month prior to study enrollment

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.