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Trial record 14 of 30 for:    " May 11, 2011":" June 10, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 25, 2011
Last Update Posted: June 13, 2011
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.
Information provided by:
NHS Lothian

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.

HIV-Associated Lipodystrophy Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

Resource links provided by NLM:

Further study details as provided by NHS Lothian:

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

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

Enrollment: 50
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
autologous fat transfer
patients received fat transfer for HIV lipodystrophy
polylactic acid
treatment with polylactic acid (PLA) for HIV lipodystrophy
bio-alcamid injections

Detailed Description:
as above

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

Exclusion Criteria:

  • known psychological disorder
  • skin allergies
  • significant medical problems precluding anaesthesia
  Contacts and Locations
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
Principal Investigator: Kenneth J Stewart, FRCSPlast NHS Lothian
  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 Submitted: May 23, 2011
First Posted: May 25, 2011
Last Update Posted: June 13, 2011
Last Verified: March 2006

Additional relevant MeSH terms:
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

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