Back to results

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Primary Purpose

HIV-facial Lipoatrophy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Artefill dermal filler

About this trial

This is an interventional treatment trial for HIV-facial Lipoatrophy focused on measuring HIV, Facial lipoatrophy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

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.

Sites / Locations

Whole Family Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artefill

Arm Description

Four treatment visits using Artefill dermal filler

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.

Full Information

NCT ID

NCT02009462

First Posted

December 5, 2013

Last Updated

July 13, 2020

Sponsor

Gerald Pierone, Jr. M.D.

Collaborators

Suneva Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02009462

Brief Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Official Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

November 2019 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gerald Pierone, Jr. M.D.

Collaborators

Suneva Medical, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-facial Lipoatrophy

Keywords

HIV, Facial lipoatrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artefill

Arm Type

Experimental

Arm Description

Four treatment visits using Artefill dermal filler

Intervention Type

Drug

Intervention Name(s)

Artefill dermal filler

Other Intervention Name(s)

polymethylmethacrylate (PMMA)

Intervention Description

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 Outcome Measure Information:

Title

Artefill for the Treatment of HIV-Associated Facial Lipoatrophy

Description

Time Frame

36 months

Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Description

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.

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Artefill for the Treatment of HIV-Associated Facial Lipoatrophy

Description

Time Frame

36 months

Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Description

To evaluate the effects of Artefill injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.

Time Frame

36 months

Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Description

To evaluate the effects of Artefill injections on the subject's psychological well-being using the Medical Outcomes study-HIV (MOS-HIV)assessment.

Time Frame

36 months

Title

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Description

To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald Pierone, Jr., M.D

Organizational Affiliation

AIDS Research and Treatment Center of the Treasure Coast

Official's Role

Principal Investigator

Facility Information:

Facility Name

Whole Family Health Center

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

We'll reach out to this number within 24 hrs