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Trial registered on ANZCTR


Trial ID
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
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
Universal Trial Number (UTN)
Trial acronym
FLASH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Facial Lipoatrophy 220 0
Condition category
Condition code
Inflammatory and Immune System 248 248 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 293 0
Change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
Timepoint [1] 293 0
At 24 weeks.
Secondary outcome [1] 651 0
Facial soft tissue volume as measured by spiral CT scan.
Timepoint [1] 651 0
Change from baseline at week 9.
Secondary outcome [2] 652 0
Physician and patient assessment of facial lipoatrophy severity.
Timepoint [2] 652 0
Change from baseline at weeks 24 and 96.
Secondary outcome [3] 653 0
Peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA).
Timepoint [3] 653 0
Change from baseline at weeks 24 and 96.
Secondary outcome [4] 654 0
Quality of life
Timepoint [4] 654 0
Change from baseline at weeks 24 and 96.
Secondary outcome [5] 655 0
Antiretroviral therapy adherence and plasma HIV-RNA
Timepoint [5] 655 0
Change from baseline at weeks 24 and 96.
Secondary outcome [6] 656 0
All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA.
Timepoint [6] 656 0
Secondary outcome [7] 657 0
All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART.
Timepoint [7] 657 0
Reported to week 96.
Secondary outcome [8] 658 0
All AEs attributable to study treatment.
Timepoint [8] 658 0
Reported to week 96.

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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation, central randomisation by phone.
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 306 0
Other
Name [1] 306 0
Public/Private
Address [1] 306 0
Country [1] 306 0
Primary sponsor type
University
Name
The University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 238 0
None
Name [1] 238 0
N?A
Address [1] 238 0
Country [1] 238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1176 0
St Vincents Hospital, Sydney
Ethics committee address [1] 1176 0
Ethics committee country [1] 1176 0
Australia
Date submitted for ethics approval [1] 1176 0
Approval date [1] 1176 0
Ethics approval number [1] 1176 0
Ethics committee name [2] 1177 0
Gold Coast Hospital, University of Adelaide
Ethics committee address [2] 1177 0
Ethics committee country [2] 1177 0
Australia
Date submitted for ethics approval [2] 1177 0
Approval date [2] 1177 0
Ethics approval number [2] 1177 0
Ethics committee name [3] 1178 0
Prince of Wales Hospital Sydney
Ethics committee address [3] 1178 0
Ethics committee country [3] 1178 0
Australia
Date submitted for ethics approval [3] 1178 0
Approval date [3] 1178 0
Ethics approval number [3] 1178 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36320 0
Address 36320 0
Country 36320 0
Phone 36320 0
Fax 36320 0
Email 36320 0
Contact person for public queries
Name 9286 0
Dianne Carey
Address 9286 0
The National Centre in HIV Epidemiology and Clinical Research (NCHER)
University of New South Wales
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9286 0
Australia
Phone 9286 0
+61 2 93850900
Fax 9286 0
+61 2 93850910
Email 9286 0
dcarey@nchecr.unsw.edu.au
Contact person for scientific queries
Name 214 0
Dianne Carey
Address 214 0
The National Centre in HIV Epidemiology and Clinical Research (NCHER)
University of New South Wales
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 214 0
Australia
Phone 214 0
+61 2 93850900
Fax 214 0
+61 2 93850910
Email 214 0
dcarey@nchecr.unsw.edu.au