Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Condition: Human Immunodeficiency Virus; Facial Lipoatrophy
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Lipodystrophy; Facies
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate and record any changes in the Quality of Life and psychological state of the
      affected study group following treatment with Bio-Alcamid.

      Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and
      contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification
      and post treatment recording of changes will be performed by, both, the Principal
      Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at
      post treatment Week 12.

      Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety
      will be determined by the rates of procedure-related events and adverse experiences
      associated with the use of Bio-Alcamid.
    

Detailed description: 
      Thirty (30) participants in the randomized portion of the study will be selected who have
      been classified as having moderate to severe facial lipoatrophy based on the three
      investigators evaluations.

      These patients will be divided into two groups -

      The Treatment Group - 15: At Day -1, the Treatment group will be established by the
      inclusion/exclusion criteria and consent forms will be signed. At Day 0 they will complete
      QOL Surveys and will receive treatment with Bio-Alcamid in the affected facial area(s). At
      Day 7, they will return to complete the QOL Surveys and allow the CITS to determine if a
      touch-up is necessary. If so, one touch-up session is permitted at week 6. The participants
      will again complete QOL Surveys and have efficacy assessments at week 12. The Treatment Group
      will continue with follow-up sessions at week 24, 48, 60 and at 96 weeks. Professional
      clinical photographs will be taken at each visit.

      The Control Group - 15: At Day -1, the Control group will be established by the
      inclusion/exclusion criteria and consent forms will be signed. At Day 0, they will complete
      QOL Surveys. They will return for visits at baseline and week 6 as well to complete QOL
      Surveys. At Week 12, they will complete the QOL Surveys and will receive a BA treatment. At
      Week 13, they will return to complete the QOL Surveys and allow the CITS to determine if a
      touch-up is necessary. If so, one touch-up session is permitted at week 18. If not, these
      participants will again complete QOL Surveys and have efficacy assessments at week 24. The
      Control Group will continue with follow-up sessions at week 48, 60, 96 and at 104 weeks.
      Professional clinical photographs will be taken at each visit.
    

Intervention name(s): BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
Intervention type(s): Device
Intervention description(s): prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment