HIV-Associated Lipodystrophy SyndromeNCT01359917
Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
An observational study of HIV-Associated Lipodystrophy Syndrome, run by NHS Lothian.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV-Associated Lipodystrophy Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with HIV facial lipoatrophy
Who may be able to join
- HIV facial lipoatrophy
- concurrent antiretrovirals
Who cannot join
- known psychological disorder
- skin allergies
- significant medical problems precluding anaesthesia
About this study
Official title: Psychological Morbidity and Facial Volume in HIV Lipodystrophy:
The hypotheses of this study were that:
- HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
- 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.
- The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.
Read the detailed description
as above
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of 3-D facial volume
3-D facial camera
Measured: 2 years
Secondary outcomes (1)
psychological outcome
derriford appearance scale hospital anxiety and depression scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-Associated Lipodystrophy SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Investigators
- Kenneth J Stewart, FRCSPlast, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359917
- Sponsor's protocol ID
- REC06/MRE00/39
- Status last verified
- Mar 2006
- First submitted
- 23 May 2011
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22153841
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Morbidity and Facial Volume in HIV Lipodystrophy:
- ClinicalTrials.gov ID
- NCT01359917
- Acronym / sponsor ID
- REC06/MRE00/39
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypotheses of this study were that:
- HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
- 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.
- The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.
Detailed description
as above
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with HIV facial lipoatrophy
Key inclusion criteria (2 listed)
- HIV facial lipoatrophy
- concurrent antiretrovirals
Key exclusion criteria (3 listed)
- known psychological disorder
- skin allergies
- significant medical problems precluding anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of 3-D facial volume
Time frame: 2 years
3-D facial camera
1 secondary outcome
psychological outcome
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
- Derived from this study: PubMed 22153841Nelson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J Stewart, FRCSPlast principal investigator
NHS Lothian
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-Associated Lipodystrophy Syndrome, run by NHS Lothian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of 3-D facial volume (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.