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

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.

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Key information

Conditions

HIV-Associated Lipodystrophy Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

as above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV facial lipoatrophy
concurrent antiretrovirals

Exclusion criteria

known psychological disorder
skin allergies
significant medical problems precluding anaesthesia

Treatment and study plan

Primary outcomes

measurement of 3-D facial volume

Time frame: 2 years

3-D facial camera

Secondary outcomes

psychological outcome

Time frame: 2 years

derriford appearance scale hospital anxiety and depression scale

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: May 25, 2011
Registry last updated: Jun 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed