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

Completed · Phase 1

Conditions studied: HIV Facial Lipoatrophy

In brief

The purpose of this study is to test the safety of Voluma and see what effects it has on HIV facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.

Key facts

Study ID

NCT02342223

Run by

Jared Jagdeo, MD, MS

People needed

20

Starts

2015-02-01

Expected to finish

2016-05-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sacramento VA Medical Center — Mather, California, United States

Full record on ClinicalTrials.gov

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