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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
Sponsor:
Information provided by:
NHS Lothian

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
Study Population
50 patients with HIV facial lipoatrophy
Criteria

Inclusion Criteria:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

Exclusion Criteria:

  • known psychological disorder
  • skin allergies
  • significant medical problems precluding anaesthesia
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01359917


Sponsors and Collaborators
NHS Lothian
Investigators
Principal Investigator: Kenneth J Stewart, FRCSPlast NHS Lothian
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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