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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00126308




Registration number
NCT00126308
Ethics application status
Date submitted
1/08/2005
Date registered
3/08/2005
Date last updated
2/04/2009

Titles & IDs
Public title
Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy
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 (FLASH)
Secondary ID [1] 0 0
ACTR012605000132640
Secondary ID [2] 0 0
V1-0 4-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-Associated Lipodystrophy 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - poly-L-lactic acid
Treatment: Devices - poly-L-lactic acid

Experimental: Immediate - poly-L-lactic acid injections

Active comparator: Delayed - poly-L-lactic acid injections


Treatment: Devices: poly-L-lactic acid
immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)

Treatment: Devices: poly-L-lactic acid
delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
Timepoint [2] 0 0
24 and 96 weeks
Secondary outcome [3] 0 0
Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA)
Timepoint [3] 0 0
24 and 96 weeks
Secondary outcome [4] 0 0
Change from baseline at weeks 24 and 96 in quality of life
Timepoint [4] 0 0
24 and 96 weeks
Secondary outcome [5] 0 0
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
Timepoint [5] 0 0
24 and 96 weeks
Secondary outcome [6] 0 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] 0 0
24 and 96 weeks
Secondary outcome [7] 0 0
All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96
Timepoint [7] 0 0
96 weeks
Secondary outcome [8] 0 0
All AEs attributable to study treatment reported to week 96
Timepoint [8] 0 0
week 96

Eligibility
Key inclusion criteria
* Aged 18 years or more with laboratory evidence of HIV-1 infection
* Received combination antiretroviral therapy (minimum of 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
No limit
Sex
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Dr Doong's Surgery - Burwood
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
407 Doctors - Sydney
Recruitment hospital [4] 0 0
AIDS Research Initiative - Sydney
Recruitment hospital [5] 0 0
Albion Street Clinic - Sydney
Recruitment hospital [6] 0 0
Holdsworth House General Practice - Sydney
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [8] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [9] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [10] 0 0
Liverpool Health Service - Sydney
Recruitment hospital [11] 0 0
Waratah Clinic, St. George Hospital - Sydney
Recruitment hospital [12] 0 0
Westmead Hospital - Westmead
Recruitment hospital [13] 0 0
Queensland Health - AIDS Medical Unit - Brisbane
Recruitment hospital [14] 0 0
Gladstone Road Medical Centre - Brisbane
Recruitment hospital [15] 0 0
Gold Coast Sexual Health Clinic - Gold Coast
Recruitment hospital [16] 0 0
Clinic 87 - Nambour
Recruitment hospital [17] 0 0
The Care and Prevention Programme - Adelaide University - Adelaide
Recruitment hospital [18] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2065 - Sydney
Recruitment postcode(s) [5] 0 0
2170 - Sydney
Recruitment postcode(s) [6] 0 0
2217 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4002 - Brisbane
Recruitment postcode(s) [9] 0 0
4101 - Brisbane
Recruitment postcode(s) [10] 0 0
4220 - Gold Coast
Recruitment postcode(s) [11] 0 0
4560 - Nambour
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
6001 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Abbott
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Bristol-Myers Squibb
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Gilead Sciences
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
GlaxoSmithKline
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/industry
Name [6] 0 0
Merck Sharp & Dohme LLC
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Hoffmann-La Roche
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
AIDS Council of New South Wales
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a 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.
Trial website
https://clinicaltrials.gov/study/NCT00126308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Carr, A/Prof
Address 0 0
Immunology and Infectious Disease Unit, St. Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00126308