Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01359917
NCT01359917CompletedNot Applicable

Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

NHS Lothian0 sites50 target enrollmentStarted: August 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
measurement of 3-D facial volume
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

as above

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •HIV facial lipoatrophy
  • •concurrent antiretrovirals

Exclusion Criteria

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

Outcomes

Primary Outcomes

measurement of 3-D facial volume

Time Frame: 2 years

3-D facial camera

Secondary Outcomes

  • psychological outcome(2 years)

Investigators

Sponsor Class
Other Gov

Similar Trials

Completed
Phase 4
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop LipodystrophyLipodystrophyHIV Infections
NCT00006190National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Completed
Phase 1
Voluma Filler Agent For The Treatment of HIV-associated Facial LipoatrophyHIV Facial Lipoatrophy
NCT02342223Jared Jagdeo, MD, MS20
Recruiting
Phase 4
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)HIVMetabolic abnormalityLipodystrophyInfection - Acquired immune deficiency syndrome (AIDS / HIV)Cardiovascular - Other cardiovascular diseasesCardiovascular disease
ACTRN12605000662662The University of New South Wales80
Completed
Not Applicable
Efficacy of EMDR Therapy, as Compared to Treatment as Usual, in Reducing Clinical Symptoms in People With HIVHIV/AIDSPsychological TraumaPTSD
NCT03848858Parc de Salut Mar40
Completed
Not Applicable
HIV Posterior Cheek EnlargementHIV Posterior Cheek Enlargement
NCT01635504University of British Columbia5