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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Artefill for the Treatment of HIV-associated Facial Lipoatrophy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria