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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359917
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : June 13, 2011
Information provided by:
NHS Lothian

Brief Summary:

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.

Condition or disease
HIV-Associated Lipodystrophy Syndrome

Detailed Description:
as above

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychological Morbidity and Facial Volume in HIV Lipodystrophy:
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Primary Outcome Measures :
  1. measurement of 3-D facial volume [ Time Frame: 2 years ]
    3-D facial camera

Secondary Outcome Measures :
  1. psychological outcome [ Time Frame: 2 years ]
    derriford appearance scale hospital anxiety and depression scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 patients with HIV facial lipoatrophy

Inclusion Criteria:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359917

Sponsors and Collaborators
NHS Lothian
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Principal Investigator: Kenneth J Stewart, FRCSPlast NHS Lothian
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Lisa Nelson, NHS Lothian Identifier: NCT01359917    
Other Study ID Numbers: REC06/MRE00/39
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: March 2006
Additional relevant MeSH terms:
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HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases