Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy
HIV Facial Lipoatrophy
About this trial
This is an interventional treatment trial for HIV Facial Lipoatrophy focused on measuring human immunodeficiency virus, facial lipoatrophy, facial lipodystrophy, hyaluronic acid, dermal filler, filler agent
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or more with laboratory evidence of HIV-1 infection and have been on HAART therapy for at least 1 (one) year.
- Not to have AIDS (CD4 count < 250) or AIDS-defining illness.
- Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached Carruthers Lipoatrophy Severity Scale (CLSS).
- Available and willing to attend study follow-up visits.
- Able and willing to give informed consent.
Exclusion Criteria:
- Any active skin inflammation or infection in or near the treatment area.
- Hypersensitivity to the components of Voluma.
- Previous treatment with Voluma or any other product for facial lipoatrophy within the past year.
- Has known bleeding disorder
- History of keloid formation
- Currently receiving systemic corticosteroids or anabolic steroids
- Currently on known anticoagulants (i.e. aspirin, non-steroidal anti-inflammatory drugs)
- Pregnancy or breastfeeding or anticipating becoming pregnant during the study period.
- Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
- Any condition that may interfere with ability to comply with study requirements.
Sites / Locations
- Sacramento VA Medical Center
Arms of the Study
Arm 1
Experimental
Voluma
Subjects will be screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and will receive subcutaneous injections of Voluma in the affected facial areas with the 'smile and fill' technique (Jagdeo 2014) based on Carruthers scoring scale. Subjects with Carruthers Score level 2 will receive total of 2-6 syringes of Voluma. Subjects with Carruthers Score level 3 will receive total of 4-8 syringes of Voluma. Subjects with Carruthers Score level 4 will receive total of 6-12 syringes of Voluma. All subjects will receive one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.