Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
This study has been completed.
Sponsor:
NHS Lothian
Information provided by:
NHS Lothian
ClinicalTrials.gov Identifier:
NCT01359917
First received: May 23, 2011
Last updated: June 9, 2011
Last verified: March 2006
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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:
Further study details as provided by NHS Lothian:
Primary Outcome Measures:
- measurement of 3-D facial volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]3-D facial camera
Secondary Outcome Measures:
- psychological outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided by NHS Lothian
Additional 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 |
| Study First Received: | May 23, 2011 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United Kingdom: National Health Service |
Additional relevant MeSH terms:
|
HIV-Associated Lipodystrophy Syndrome Lipodystrophy HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Virus Diseases |
ClinicalTrials.gov processed this record on March 02, 2015