HIV-facial LipoatrophyPhase 1NCT02009462
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
A Phase 1 study testing Artefill dermal filler in people with HIV-facial Lipoatrophy, run by Gerald Pierone, Jr. M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-facial Lipoatrophy
- What is being tested?
- Artefill dermal filler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Whole Family Health Center
Vero Beach, Florida, 32960
About this study
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.
Read the 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.
- Conditions
- HIV-facial Lipoatrophy
- Being tested
- Artefill dermal filler
- Keywords
- HIV, Facial lipoatrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artefill dermal fillerDrug
Also called polymethylmethacrylate (PMMA)
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.
| Study group | Role | What they receive |
|---|---|---|
| Artefill | Experimental | Four treatment visits using Artefill dermal filler Receives: Drug: Artefill dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
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.
Measured: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
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.
Measured: 36 months
Secondary outcomes (4)
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
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.
Measured: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the effects of Artefill injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.
Measured: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the effects of Artefill injections on the subject's psychological well-being using the Medical Outcomes study-HIV (MOS-HIV)assessment.
Measured: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
To evaluate the acceptability and tolerability of Artefill injections as reported by subjects.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-facial LipoatrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerald Pierone, Jr. M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Suneva Medical, Inc.
- Responsible party
- Sponsor-investigator, Gerald Pierone, Jr. M.D., AIDS Research and Treatment Center of the Treasure Coast
- Investigators
- Gerald Pierone, Jr., M.D, Principal investigator, AIDS Research and Treatment Center of the Treasure Coast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009462
- Sponsor's protocol ID
- ARTCTC-01-001
- Status last verified
- Jul 2020
- First submitted
- 5 Dec 2013
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artefill for the Treatment of HIV-associated Facial Lipoatrophy
- ClinicalTrials.gov ID
- NCT02009462
- Acronym / sponsor ID
- ARTCTC-01-001
- Conditions
- HIV-facial Lipoatrophy
- Keywords
- HIV, Facial lipoatrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gerald Pierone, Jr. M.D.University, hospital or other
- Collaborators
- Suneva Medical, Inc.
- Study start
- Dec 2013
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artefill | Experimental | Drug: Artefill dermal fillerFour treatment visits using Artefill dermal filler |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artefill dermal fillerAlso: polymethylmethacrylate (PMMA)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. | Drug | Artefill |
Primary outcome
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.
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.
4 secondary outcomes
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Time frame: 36 months
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Pierone, Jr., M.D principal investigator
AIDS Research and Treatment Center of the Treasure Coast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artefill dermal filler in people with HIV-facial Lipoatrophy, run by Gerald Pierone, Jr. M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Artefill for the Treatment of HIV-Associated Facial Lipoatrophy (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.