Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome

Overview

The hypotheses of this study were that: 1. HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression. 2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical volume of treated areas. 3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

Full Title of Study: “Psychological Morbidity and Facial Volume in HIV Lipodystrophy:”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2009

Detailed Description

as above

Arms, Groups and Cohorts

  • autologous fat transfer
    • patients received fat transfer for HIV lipodystrophy
  • polylactic acid
    • treatment with polylactic acid (PLA) for HIV lipodystrophy
  • bio-alcamid
    • bio-alcamid injections

Clinical Trial Outcome Measures

Primary Measures

  • measurement of 3-D facial volume
    • Time Frame: 2 years
    • 3-D facial camera

Secondary Measures

  • psychological outcome
    • Time Frame: 2 years
    • derriford appearance scale hospital anxiety and depression scale

Participating in This Clinical Trial

Inclusion Criteria

  • HIV facial lipoatrophy – concurrent antiretrovirals Exclusion Criteria:

  • known psychological disorder – skin allergies – significant medical problems precluding anaesthesia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NHS Lothian
  • Provider of Information About this Clinical Study
    • Dr Lisa Nelson, NHS Lothian
  • Overall Official(s)
    • Kenneth J Stewart, FRCSPlast, Principal Investigator, NHS Lothian

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