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

This study has been completed.
Sponsor:
Information provided by:
NHS Lothian
ClinicalTrials.gov Identifier:
NCT01359917
First received: May 23, 2011
Last updated: June 9, 2011
Last verified: March 2006
  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:

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
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

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:
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 15, 2014