Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
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ClinicalTrials.gov Identifier: NCT01359917 |
Recruitment Status
:
Completed
First Posted
: May 25, 2011
Last Update Posted
: June 13, 2011
|
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The hypotheses of this study were that:
- HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
- 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.
- The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.
Condition or disease |
---|
HIV-Associated Lipodystrophy Syndrome |
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 |

Group/Cohort |
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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
|
- measurement of 3-D facial volume [ Time Frame: 2 years ]3-D facial camera
- psychological outcome [ Time Frame: 2 years ]derriford appearance scale hospital anxiety and depression scale

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV facial lipoatrophy
- concurrent antiretrovirals
Exclusion Criteria:
- known psychological disorder
- skin allergies
- significant medical problems precluding anaesthesia

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 ClinicalTrials.gov identifier (NCT number): NCT01359917
Principal Investigator: | Kenneth J Stewart, FRCSPlast | NHS Lothian |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr Lisa Nelson, NHS Lothian |
ClinicalTrials.gov Identifier: | NCT01359917 History of Changes |
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:
Lipodystrophy 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 |