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

June 9, 2011 updated by: NHS Lothian

Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

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.

Study Overview

Status

Completed

Conditions

Detailed Description

as above

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients with HIV facial lipoatrophy

Description

Inclusion Criteria:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of 3-D facial volume
Time Frame: 2 years
3-D facial camera
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychological outcome
Time Frame: 2 years
derriford appearance scale hospital anxiety and depression scale
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Investigators

  • Principal Investigator: Kenneth J Stewart, FRCSPlast, NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

June 13, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

March 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC06/MRE00/39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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