Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy

HIV facial lipoatrophy (volume loss) is an increasing concern with patients on Highly Active
Anti-Retroviral Therapy (HAART) because it affects the quality-of-life and adherence to
medication regimen. Treatment of HIV facial lipoatrophy helps to improve patient wellness by
removing the social stigma associated with HIV facial lipoatrophy. Currently, there are few
medical therapies that can treat HIV facial lipoatrophy and are FDA-approved for this
indication. Juvéderm Voluma (Allergan) may benefit patients on HAART because it may provide
a more immediate aesthetic enhancement and potentially has fewer adverse effects, which
results in a more natural appearing facial enhancement outcome. Voluma is the only agent
that is FDA-approved for facial volume loss. We anticipate Voluma having less adverse
effects than current FDA-approved drugs for HIV lipoatrophy as Voluma is a hyaluronic acid
(HA)-based agent. The benefit of using hyaluronidase to "correct" or "modify" facial
HA-based volume therapy is also a benefit for HIV patients, which currently does not exist
as a post-injection modification option for other FDA-approved filling agents used to treat
patients with HIV facial lipoatrophy. Voluma is currently FDA-approved for correction of
age-related volume loss in the midface, and there's no alteration in the chemical or
biophysical properties of Voluma that is being used in our proposed study. In addition to
conventional injection techniques, we will implement the 'smile and fill' technique
pioneered by our clinical research group to achieve better mid-face aesthetic outcomes.

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.