- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009462
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Vero Beach, Florida, United States, 32960
- Whole Family Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artefill
Four treatment visits using Artefill dermal filler
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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36 months
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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.
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36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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36 months
|
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.
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36 months
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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.
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36 months
|
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Time Frame: 36 months
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To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.
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36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerald Pierone, Jr., M.D, AIDS Research and Treatment Center of the Treasure Coast
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARTCTC-01-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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