Artefill for the Treatment of HIV-associated Facial Lipoatrophy

NCT02009462 | Completed Phase 1 DMC

• 1 other identifier: ARTCTC-01-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-facial Lipoatrophy

Keywords

HIV; Facial lipoatrophy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Artefill for the Treatment of HIV-Associated Facial Lipoatrophy

  36 months

• Artefill for the Treatment of HIV-associated Facial Lipoatrophy

  36 months

• Artefill for the Treatment of HIV-associated Facial Lipoatrophy

  36 months

• Artefill for the Treatment of HIV-associated Facial Lipoatrophy

  36 months

Study Arms (1)

Artefill

EXPERIMENTAL

Four treatment visits using Artefill dermal filler

Drug: Artefill dermal filler

Interventions

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.

Also known as: polymethylmethacrylate (PMMA)

Artefill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female between 18-80 years of age inclusive at the time of signing the informed consent.
• Subject desires treatment for facial volume loss.
• Subject has HIV infection with moderated to severe facial lipoatrophy based on the Modified James Scale grades II-IV.
• Subject has viral load \<400 copies/mL.
• Subject has CD4 lymphocyte counts \>200/mm.
• Subject has documented negative Artefill skin test or has received treatment with Artefill in the past without evidence of hypersensitivity reaction.
• 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.

You may not qualify if:

• Subject has any skin pathology, inflammatory skin disease, or condition that could interfere with the evaluation of the treatment areas.
• Subject has a history of systemic granulomatous diseases (sarcoid, Wegeners, etc) or connective tissue disease (lupus, dermatomyositis, ect)
• Subject has history of keloid formation or hypertrophic scarring.
• 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
• \. 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.
• \. 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.
• \. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• \. Subject has substance abuse, depression, or other issues that, according to the investigator's judgment, would interfere with conduct of the study.

Sponsors & Collaborators

• Gerald Pierone, Jr. M.D.: lead
• Suneva Medical, Inc.: collaborator

Study Sites (1)

Whole Family Health Center

Vero Beach, Florida, 32960, United States

Location

MeSH Terms

Interventions

Polymethyl Methacrylate

Intervention Hierarchy (Ancestors)

Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gerald Pierone, Jr., M.D

  AIDS Research and Treatment Center of the Treasure Coast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 12, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

US (1)