Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV-facial Lipoatrophy	Drug: Artefill dermal filler	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Study Start Date :	December 2013
Estimated Primary Completion Date :	November 2019
Estimated Study Completion Date :	November 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Artefill; Four treatment visits using Artefill dermal filler	Drug: 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.; Other Name: polymethylmethacrylate (PMMA)

Outcome Measures

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Primary Outcome Measures :

1. Artefill for the Treatment of HIV-Associated Facial Lipoatrophy [ Time Frame: 36 months ]
   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.
2. Artefill for the Treatment of HIV-associated Facial Lipoatrophy [ Time Frame: 36 months ]
   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 :

1. Artefill for the Treatment of HIV-Associated Facial Lipoatrophy [ Time Frame: 36 months ]
   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.
2. Artefill for the Treatment of HIV-associated Facial Lipoatrophy [ Time Frame: 36 months ]
   To evaluate the effects of Artefill injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.
3. Artefill for the Treatment of HIV-associated Facial Lipoatrophy [ Time Frame: 36 months ]
   To evaluate the effects of Artefill injections on the subject's psychological well-being using the Medical Outcomes study-HIV (MOS-HIV)assessment.
4. Artefill for the Treatment of HIV-associated Facial Lipoatrophy [ Time Frame: 36 months ]
   To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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Locations

United States, Florida
Whole Family Health Center
Vero Beach, Florida, United States, 32960

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

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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
First Posted:	December 12, 2013
Last Update Posted:	January 9, 2018
Last Verified:	January 2018

Keywords provided by Gerald Pierone, Jr. M.D., 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; Antimutagenic Agents; Protective Agents; Physiological Effects of Drugs