NCT01359917

Brief Summary

The hypotheses of this study were that:

  1. 1.HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
  2. 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. 3.The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
Last Updated

June 13, 2011

Status Verified

March 1, 2006

Enrollment Period

2.9 years

First QC Date

May 23, 2011

Last Update Submit

June 9, 2011

Conditions

HIV-Associated Lipodystrophy Syndrome

Outcome Measures

Primary Outcomes (1)

  • measurement of 3-D facial volume

    3-D facial camera

    2 years

Secondary Outcomes (1)

  • psychological outcome

    2 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with HIV facial lipoatrophy

You may qualify if:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nelson L, Stewart KJ. Psychological morbidity and facial volume in HIV lipodystrophy: quantification of treatment outcome. J Plast Reconstr Aesthet Surg. 2012 Apr;65(4):439-47. doi: 10.1016/j.bjps.2011.11.024. Epub 2011 Dec 5.

    PMID: 22153841DERIVED

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kenneth J Stewart, FRCSPlast

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 13, 2011

Record last verified: 2006-03