CompletedPhase 1

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

United States31 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Artefill for the Treatment of HIV-Associated Facial Lipoatrophy

Timeframe: 36 months

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Timeframe: 36 months

Trial details

NCT IDNCT02009462

SponsorGerald Pierone, Jr. M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11

View on ClinicalTrials.gov More HIV-facial Lipoatrophy trials