Artefill for the Treatment of HIV-associated Facial Lipoatrophy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by AIDS Research and Treatment Center of the Treasure Coast
Sponsor:
Collaborator:
Suneva Medical, Inc.
Information provided by (Responsible Party):
Gerald Pierone, Jr. M.D., AIDS Research and Treatment Center of the Treasure Coast
ClinicalTrials.gov Identifier:
NCT02009462
First received: December 5, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
HIV-facial Lipoatrophy
Drug: Artefill dermal filler
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Resource links provided by NLM:


Further study details as provided by AIDS Research and Treatment Center of the Treasure Coast:

Primary Outcome Measures:
  • Artefill for the Treatment of HIV-Associated Facial Lipoatrophy [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artefill
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 30mL of Artefill (all treatments combined) will be used per subject. The goal will be to achieve optimal facial correction over the course of these treatments. One touch-up treatment will be allowed at Year 1 (12 month visit).
Drug: Artefill dermal filler
Other Name: polymethylmethacrylate (PMMA)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009462

Contacts
Contact: Gerald Pierone, Jr., M.D. 772-978-9556 pieroneg@verotcid.com
Contact: Juliana Stradley, A.R.N.P. 772-978-9556 jstradley@wholefamilyhealthcenter.com

Locations
United States, Florida
Whole Family Health Center Recruiting
Vero Beach, Florida, United States, 32960
Contact: Mona White, L.P.N.    772-978-9556    mwhite@verotcid.com   
Contact: Joanne Giordano, L.P.N.    772-978-9556    jgiordano@wholefamilyhealthcenter.com   
Principal Investigator: Gerald Pierone, Jr., M.D.         
Sub-Investigator: Juliana Stradley, A.R.N.P.         
Sponsors and Collaborators
Gerald Pierone, Jr. M.D.
Suneva Medical, Inc.
Investigators
Principal Investigator: Gerald Pierone, Jr., M.D AIDS Research and Treatment Center of the Treasure Coast
  More Information

No publications provided

Responsible Party: Gerald Pierone, Jr. M.D., Principle Investigator, AIDS Research and Treatment Center of the Treasure Coast
ClinicalTrials.gov Identifier: NCT02009462     History of Changes
Other Study ID Numbers: ARTCTC-01-001
Study First Received: December 5, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AIDS Research and Treatment Center of the Treasure Coast:
HIV
Facial lipoatrophy

Additional relevant MeSH terms:
Facies
Lipodystrophy
Disease Attributes
Pathologic Processes
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014