Artefill for the Treatment of HIV-associated Facial Lipoatrophy

NCT ID: NCT02009462

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-11-30

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.

Detailed 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.

Conditions

HIV-facial Lipoatrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artefill

Four treatment visits using Artefill dermal filler

Group Type: EXPERIMENTAL

Artefill dermal filler

Intervention Type: 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.

Interventions

Artefill dermal filler

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.

Intervention Type: DRUG

Other Intervention Names

polymethylmethacrylate (PMMA)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suneva Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Gerald Pierone, Jr. M.D.

OTHER

Sponsor Role: lead

Responsible Party

Gerald Pierone, Jr. M.D.

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gerald Pierone, Jr., M.D

Role: PRINCIPAL_INVESTIGATOR

AIDS Research and Treatment Center of the Treasure Coast

Locations

Whole Family Health Center

Vero Beach, Florida, United States

Countries

United States

Other Identifiers

ARTCTC-01-001

Identifier Type: -

Identifier Source: org_study_id