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

This study has been completed.

Sponsor:

Information provided by:

NHS Lothian

ClinicalTrials.gov Identifier:

NCT01359917

First received: May 23, 2011

Last updated: June 9, 2011

Last verified: March 2006

History of Changes

Purpose

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
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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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)

Groups/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

Detailed Description:

as above

Eligibility


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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01359917

Sponsors and Collaborators

NHS Lothian

Investigators


Principal Investigator:	Kenneth J Stewart, FRCSPlast	NHS Lothian

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nelson L, Stewart KJ. Psychological morbidity and facial volume in HIV lipodystrophy: quantification of treatment outcome. J Plast Reconstr Aesthet Surg. 2012 Apr;65(4):439-47. doi: 10.1016/j.bjps.2011.11.024. Epub 2011 Dec 5.


Responsible Party:	Dr Lisa Nelson, NHS Lothian
ClinicalTrials.gov Identifier:	NCT01359917 History of Changes
Other Study ID Numbers:	REC06/MRE00/39
Study First Received:	May 23, 2011
Last Updated:	June 9, 2011

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

ClinicalTrials.gov processed this record on June 22, 2017

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