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

Completed

• Conditions: HIV-Associated Lipodystrophy Syndrome

• Registration Number: NCT01359917
• Lead Sponsor: NHS Lothian

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.

Detailed Description

as above

Study Timeline

• Status Verified: 2006-03
• Study Start: 2006-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-25
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• HIV facial lipoatrophy
• concurrent antiretrovirals

Exclusion Criteria

• known psychological disorder
• skin allergies
• significant medical problems precluding anaesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurement of 3-D facial volume	2 years	3-D facial camera

Secondary Outcome Measures

Name	Time	Method
psychological outcome	2 years	derriford appearance scale hospital anxiety and depression scale