Overview

This trial is active, not recruiting.

Condition hiv-facial lipoatrophy
Treatment artefill dermal filler
Phase phase 1
Sponsor Gerald Pierone, Jr. M.D.
Collaborator Suneva Medical, Inc.
Start date December 2013
End date June 2017
Trial size 30 participants
Trial identifier NCT02009462, ARTCTC-01-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Four treatment visits using Artefill dermal filler
artefill dermal filler polymethylmethacrylate (PMMA)
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.

Primary Outcomes

Measure
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
time frame: 36 months

Secondary Outcomes

Measure
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
time frame: 36 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Principal investigator Gerald Pierone, Jr., M.D
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AIDS Research and Treatment Center of the Treasure Coast.