Clinical Trials

MainTitle

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

This study has been completed
Sponsor
NHS Lothian


Information provided by (Responsible Party)
NHS Lothian
ClinicalTrials.gov Identifier
NCT01359917

First received: May 23, 2011
Last updated: June 9, 2011
Last Verified: March 2006
History of Changes
Purpose

Purpose

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.

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:

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)

Arms
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

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


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:
HIV-Associated Lipodystrophy Syndrome
Lipodystrophy

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.