NCT01359917

Completed

Psychological Morbidity and Facial Volume in HIV Lipodystrop...

NHS Lothian Source

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Other study identifiers

Sponsor study identifier

REC06/MRE00/39

Study Type

observational

Actual enrollment (reported)

50

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 50 participants
Study completion date: July 2009
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)
Study Completion
July 2009
Actual (reported)
First Submitted
May 23, 2011
Actual (reported)
First Posted
May 25, 2011
Actual (reported)

Last Updated: June 13, 2011
Status Verified: March 2006
Last Update Submitted: 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

Sponsors & Collaborators

NHS Lothian
Governmentlead

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, Metabolic

Study Officials

Kenneth J Stewart, FRCSPlast
NHS Lothian
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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Unknown

NCT00122668

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Phase 4Terminated

NCT00148850

Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients

Phase 3Terminated

concurrent antiretrovirals

You may not qualify if:

known psychological disorder
skin allergies
significant medical problems precluding anaesthesia

Contact the study team to confirm eligibility.

Skin Diseases

Skin and Connective Tissue Diseases

Lipid Metabolism Disorders

Metabolic Diseases

Nutritional and Metabolic Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

Last Updated

June 13, 2011

Record last verified: 2006-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01359917
Data provider: ClinicalTrials.gov
Source updated: 2011-06-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:56 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

autologous fat transfer

polylactic acid

bio-alcamid

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record