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Trial registered on ANZCTR
Registration number
ACTRN12605000132640
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
12/08/2005
Date last updated
11/05/2009
Type of registration
Prospectively registered
Titles & IDs
Public title
Facial Lipoatrophy Trial
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Scientific title
A multi-centre, open-label, randomised study to assess the efficacy, durability and safety of immediate versus deferred injections of poly-L-lactic acid for HIV facial lipoatrophy
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Universal Trial Number (UTN)
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Trial acronym
FLASH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Facial Lipoatrophy
220
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Condition category
Condition code
Inflammatory and Immune System
248
248
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA).
Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
293
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Change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
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Assessment method [1]
293
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Timepoint [1]
293
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At 24 weeks.
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Secondary outcome [1]
651
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Facial soft tissue volume as measured by spiral CT scan.
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Assessment method [1]
651
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Timepoint [1]
651
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Change from baseline at week 9.
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Secondary outcome [2]
652
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Physician and patient assessment of facial lipoatrophy severity.
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Assessment method [2]
652
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Timepoint [2]
652
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Change from baseline at weeks 24 and 96.
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Secondary outcome [3]
653
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Peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA).
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Assessment method [3]
653
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Timepoint [3]
653
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Change from baseline at weeks 24 and 96.
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Secondary outcome [4]
654
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Quality of life
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Assessment method [4]
654
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Timepoint [4]
654
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Change from baseline at weeks 24 and 96.
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Secondary outcome [5]
655
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Antiretroviral therapy adherence and plasma HIV-RNA
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Assessment method [5]
655
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Timepoint [5]
655
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Change from baseline at weeks 24 and 96.
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Secondary outcome [6]
656
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All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA.
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Assessment method [6]
656
0
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Timepoint [6]
656
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Secondary outcome [7]
657
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All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART.
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Assessment method [7]
657
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Timepoint [7]
657
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Reported to week 96.
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Secondary outcome [8]
658
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All AEs attributable to study treatment.
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Assessment method [8]
658
0
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Timepoint [8]
658
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Reported to week 96.
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Eligibility
Key inclusion criteria
Laboratory evidence of HIV-1 infection- received combination antiretroviral therapy (min 2 agents) - antiretroviral regimen should be stable for at least 12 weeks prior to entry with no changes planned during the first 48 weeks. For subjects not on antiretroviral therapy at entry there should be no intent to commence therapy in first 24 weeks - moderate or severe facial lipoatrophy and lipodystrophy at one or more other sites- provide written, informed consent.
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Minimum age
18
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Active AIDS-defining illness including active HIV wasting- active herpes labialis or any acute or currently present chronic skin disease (infection/inflammation) on/near area to be treated- currently on anticoagulants or any coagulopathy that would preclude safe deep subcutaneous injections - women: pregnant, breastfeeding or have positive pregnancy test or not willing to use adequate contraception if of child-bearing potential- concomitant therapy with anabolic steroids (except testosterone replacement), corticosteroids at greater than replacement doses, growth hormone or any currently available or experimental agent to improve appetite or weight - testosterone replacement for less than 6 months or at greater than replacement doses - subjects who have discontinued any prohibited concomitant agent/s must cease this therapy at least 30 days prior to screening - prior use of any facial dermal filling/tissue expansion agent/s - any condition which may interfere with ability to comply with study requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation, central randomisation by phone.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restriction method: full minimisation by age, facial lipoatrophy, ART. Random allocation by computer software (SAS in-house program)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
3/09/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
306
0
Other
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Name [1]
306
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Public/Private
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Address [1]
306
0
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Country [1]
306
0
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Primary sponsor type
University
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Name
The University of New South Wales
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Address
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Country
Australia
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Secondary sponsor category [1]
238
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None
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Name [1]
238
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N?A
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Address [1]
238
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Country [1]
238
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1176
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St Vincents Hospital, Sydney
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Ethics committee address [1]
1176
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Ethics committee country [1]
1176
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Australia
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Date submitted for ethics approval [1]
1176
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Approval date [1]
1176
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Ethics approval number [1]
1176
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Ethics committee name [2]
1177
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Gold Coast Hospital, University of Adelaide
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Ethics committee address [2]
1177
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Ethics committee country [2]
1177
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Australia
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Date submitted for ethics approval [2]
1177
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Approval date [2]
1177
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Ethics approval number [2]
1177
0
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Ethics committee name [3]
1178
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Prince of Wales Hospital Sydney
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Ethics committee address [3]
1178
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Ethics committee country [3]
1178
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Australia
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Date submitted for ethics approval [3]
1178
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Approval date [3]
1178
0
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Ethics approval number [3]
1178
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
36320
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Address
36320
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Country
36320
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Phone
36320
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Fax
36320
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Email
36320
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Contact person for public queries
Name
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Dianne Carey
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Address
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The National Centre in HIV Epidemiology and Clinical Research (NCHER)
University of New South Wales
Level 2
376 Victoria Street
Darlinghurst NSW 2010
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Country
9286
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Australia
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Phone
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+61 2 93850900
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Fax
9286
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+61 2 93850910
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Email
9286
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[email protected]
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Contact person for scientific queries
Name
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Dianne Carey
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Address
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The National Centre in HIV Epidemiology and Clinical Research (NCHER)
University of New South Wales
Level 2
376 Victoria Street
Darlinghurst NSW 2010
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Country
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Australia
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Phone
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+61 2 93850900
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Fax
214
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+61 2 93850910
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Email
214
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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